[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]
VA RESEARCH: FOCUSING ON FUNDING, FINDINGS, AND PARTNERSHIPS
=======================================================================
JOINT HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
JOINT WITH
SUBCOMMITTEE ON OVERSIGHT & INVESTIGATIONS
OF THE
COMMITTEE ON VETERANS' AFFAIRS
U.S. HOUSE OF REPRESENTATIVES
ONE HUNDRED FIFTEENTH CONGRESS
SECOND SESSION
__________
THURSDAY, MAY 17, 2018
__________
Serial No. 115-60
__________
Printed for the use of the Committee on Veterans' Affairs
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
35-488 WASHINGTON : 2019
--------------------------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Publishing Office,
http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center,
U.S. Government Publishing Office. Phone 202-512-1800, or 866-512-1800 (toll-free).
E-mail, [email protected].
COMMITTEE ON VETERANS' AFFAIRS
DAVID P. ROE, Tennessee, Chairman
GUS M. BILIRAKIS, Florida, Vice- TIM WALZ, Minnesota, Ranking
Chairman Member
MIKE COFFMAN, Colorado MARK TAKANO, California
BRAD R. WENSTRUP, Ohio JULIA BROWNLEY, California
AMATA COLEMAN RADEWAGEN, American ANN M. KUSTER, New Hampshire
Samoa BETO O'ROURKE, Texas
MIKE BOST, Illinois KATHLEEN RICE, New York
BRUCE POLIQUIN, Maine J. LUIS CORREA, California
NEAL DUNN, Florida CONOR LAMB, Pennsylvania
JODEY ARRINGTON, Texas ELIZABETH ESTY, Connecticut
JOHN RUTHERFORD, Florida SCOTT PETERS, California
CLAY HIGGINS, Louisiana
JACK BERGMAN, Michigan
JIM BANKS, Indiana
JENNIFFER GONZALEZ-COLON, Puerto
Rico
Jon Towers, Staff Director
Ray Kelley, Democratic Staff Director
SUBCOMMITTEE ON HEALTH
BRAD WENSTRUP, Ohio, Chairman
GUS BILIRAKIS, Florida JULIA BROWNLEY, California,
AMATA RADEWAGEN, American Samoa Ranking Member
NEAL DUNN, Florida MARK TAKANO, California
JOHN RUTHERFORD, Florida ANN MCLANE KUSTER, New Hampshire
CLAY HIGGINS, Louisiana BETO O'ROURKE, Texas
JENNIFER GONZALEZ-COLON, Puerto LUIS CORREA, California
Rico
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
JACK BERGMAN, Michigan, Chairman
MIKE BOST, Illinois ANN MCLANE KUSTER, New Hampshire,
BRUCE POLIQUIN, Maine Ranking Member
NEAL DUNN, Florida KATHLEEN RICE, New York
JODEY ARRINGTON, Texas SCOTT PETERS, California
JENNIFER GONZALEZ-COLON, Puerto KILILI SABLAN, Northern Mariana
Rico Islands
Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public
hearing records of the Committee on Veterans' Affairs are also
published in electronic form. The printed hearing record remains the
official version. Because electronic submissions are used to prepare
both printed and electronic versions of the hearing record, the process
of converting between various electronic formats may introduce
unintentional errors or omissions. Such occurrences are inherent in the
current publication process and should diminish as the process is
further refined.
C O N T E N T S
----------
Thursday, May 17, 2018
Page
VA Research: Focusing On Funding, Findings, And Partnerships..... 1
OPENING STATEMENTS
Honorable Neal Dunn, Acting Chairman............................. 1
Honorable Julia Brownley, Ranking Member, Subcommittee on Health. 2
WITNESSES
Robin L. Rusconi J.D., Chair, Board of Directors, National
Association of Veterans' Research & Education Foundations...... 4
Paul Klotman M.D., President, Chief Executive Officer, and
Executive Dean, Baylor College of Medicine, On behalf of
Association of American Medical Colleges....................... 5
Carolyn Clancy M.D., Executive in Charge, Veterans Health
Administration, U.S. Department of Veterans Affairs............ 7
Accompanied by:
Rachel B. Ramoni D.M.D., Sc.D., Chief Research and
Development Officer, Veterans Health Administration, U.S.
Department of Veterans Affairs
STATEMENTS FOR THE RECORD
Roger Murray Executive Director, the Coalition to Heal Invisible
Wounds......................................................... 37
Rick Weidman, Executive Director for Policy & Government Affairs,
Vietnam Veterans of America (VVA).............................. 41
Ms. Jacqueline Garrick, LCSW-C, Whistleblowers of America........ 43
National Association of Veterans' Research and Education
Foundations (NAVREF)........................................... 48
VA RESEARCH: FOCUSING ON FUNDING, FINDINGS, AND PARTNERSHIPS
----------
Thursday, May 17, 2018
U.S. House of Representatives,
Committee on Veterans' Affairs,
Subcommittee on Health
Washington, D.C.
The Subcommittees met, pursuant to notice, at 10:03 a.m.,
in Room 334, Cannon House Office Building, Hon. Neal Dunn
presiding.
Present: Representatives Bergman, Dunn, Bost, Poliquin,
Arrington, Higgins, Coffman, Brownley, Kuster, Rice, O'Rourke,
Correa, and Lamb.
OPENING STATEMENT OF NEAL DUNN, ACTING CHAIRMAN
Mr. Dunn. This meeting has come to order. Good morning, I
thank all of you for joining us today to discuss the Department
of Veterans Affairs medical and prosthetic research program.
Before I begin, I would like to ask unanimous consent for our
friend and fellow Committee Member Congressman Coffman from
Colorado to join us on the dais for today's proceeding, when he
comes in we will seat him.
Without objection, that is ordered.
All right. Well, current law requires VA to conduct
research in order to carry out more effectively the primary
function of veteran's health administration in order to
contribute to the Nation's knowledge about disease and
disability. The VA research program has attracted high quality
clinician researchers to VA medical centers and led to many
important partnerships. This has resulted in discoveries that
have benefitted everybody in this room. You will hear the VA
tout some of these most notable discoveries this morning. They
range from the pacemaker in 1959 to the shingles vaccine in
2006.
Despite these successes, the Committee has become
increasingly concerned that the VA's research program is in
need of refocusing in several important areas. First, it is not
clear that the majority of the research that the VA conducts
displays a concentrated focus on veteran specific conditions
and concerns.
There are many valuable research topics such as obesity and
heart disease that are very deserving of research dollars and
attention. But the VA's research program is meant to support
research on issues that are unique to or particularly prevalent
among veterans, and may not be receiving the funding and
attention they deserve by other research entities. And these
issues are such as toxic exposures, traumatic brain injuries,
and post-traumatic stress disorder.
Secondly, there are concerns that VA medical facilities are
not complying with the VA policy by administering grants from
outside entities through VA non-profit research and education
corporations to the extent that is possible. The vast majority
of VA researchers are duly appointed at both a VA medical
facility and a nearby academic affiliate, which can create
conflicts of interest when it comes time to determine where our
given grant is administered.
There are significant financial considerations inherent in
that determination, and the VA has to make sure that the
department is given due consideration and not leaving a cent of
potential research funding on the table and out of the veterans
reach. Finally, there are concerns that the VA's not getting a
significant return on its investment in research overall.
A statement from the record from the Vietnam Veterans of
America said it perhaps most succinctly. ``How much of what VA
research produced recently is of significant benefit to
veterans?'' And I have no doubt that the VA's researchers are
leaders in their field, making great progress on a regular
basis, but we are not sure that enough of what VA researchers
are discovering is being translated efficiently and effectively
into the VA medical centers and clinics to benefit veterans
across the country.
I am grateful today for our witnesses for their attendance
here this morning to discuss these issues with us. One thing I
will note before yielding is that the Subcommittee on health
will be holding another hearing on June 8th that will focus
specifically on burn pit research. I am looking forward to that
and diving deeper into that specific research efforts at that
hearing and not today.
I will yield to Ranking Member Brownley for any opening
statement that she may at this time. Thank you.
OPENING STATEMENT OF JULIA BROWNLEY, RANKING MEMBER,
SUBCOMMITTEE ON HEALTH
Ms. Brownley. Thank you, Mr. Chairman. This morning this
Subcommittee will delve into issues involving VA's mission to
discover knowledge, develop researchers and health care
leaders, and create innovations to advance health care for
veterans and the Nation.
The successful advancement of this mission has positioned
VA as the largest single provider of medical training in the
United States. Today, over 70 percent of health care providers
have received training through the VA. The partnerships VA has
established with academic institutions and VA non-profit
corporation have proven integral to VA's advancement of
veteran-centric research.
VA's relationship to its academic affiliates is essential
if VA is to provide the level of health care that we all expect
for our veterans. This is why Congress, the VA, and it academic
affiliates must work together to address areas that need
improvement.
While our overall health care system reaps the benefits of
VA inventions, VA also benefits by being able to rely on the
high-quality providers and specialists that this type of
research attracts. VA physicians are often on the leading edge
of medical knowledge and leaders in their field of practice.
For instance, earlier this year the Minneapolis VA
published a study that found that opioid pain killer are no
more effective than safer alternatives in long-term treatment
of patients with chronic pain. Not only is this information
timely but it will likely shape Federal policies surrounding
the prescribing of opioids in the future and save thousands of
Americans from falling victim to opioid addiction.
Because of the important work VA's Office of Research and
Development has accomplished, I wish to examine how we can
better support VA research and research conducted by our
academic affiliates in VA non-profit research corporations. I
am concerned that VA's current research budget is not keeping
pace with inflation. And if NIH awards significantly fewer
research grants, this will have a negative effect on VA's
ability to develop treatments for our veterans.
If funding for VA research continues to be lacking, I want
to know about how VA can continue to leverage private
investment in non-profit funding through our non-profit
research corporations and through our academic affiliates to
make up for Federal research funding shortfalls.
Finally, I want to continue to work with Ranking Member
Kuster and our colleagues across the aisle to ensure VA is
properly overseeing its research programs and the
administration of NIH funded research through the VA's non-
profits research corporations and its academic affiliates.
I would also like to better understand when it is
appropriate for VA non-profit corporations and academic
affiliates to administer NIH grants, and ensure VA is following
its current policy directives. We need to come together to
figure out the best way to ensure vital research to advance
veterans health care needs is funded, and that it is
administered properly so that this funding results in
treatments that improve, and in some cases, save veterans
lives. Educating our Nation's health care providers and
developing medical breakthroughs to provide treatment to our
veterans are part of VA's core mission. It is vital that we, as
Members of Congress, support this mission.
So thank you, Mr. Chairman, Dr. Dunn. And I yield back the
balance of my time.
Mr. Dunn. Thank you very much Representative Brownley.
I will make note that Chairman Bergman and Ranking Member
Kuster will be making closing statements at the end of our
hearing. And so I welcome our panel, and I will introduce you
now.
First, we have Robin Rusconi, Chair of the Board of
Directors for the National Association of Veterans' Research &
Education Foundations. Next, we have Dr. Paul Klotman who is a
nephrologist by training, the President and Chief Executive
Officer, and Dean of Baylor College of Medicine, and here on
behalf of the Association of American Medical Colleges. And I
will make note that they are also the very first VA hospital
ever.
Also, Dr. Carolyn Clancy, Executive in Charge of the
Veterans Health Administration for the U.S. Department of
Veteran Affairs, and who is accompanied also by Dr. Rachel
Ramoni, VA's Chief Research and Development Officer. Welcome
panel, we thank you all for being here with us this afternoon.
And, Mrs. Rusconi, I believe we will start with you. And
you are now recognized for five minutes.
STATEMENT OF ROBIN RUSCONI
Ms. Rusconi. Chairman Bergman and Dunn, Ranking Members
Kuster and Brownley, distinguished Members of the
Subcommittees, thank you for holding this important hearing.
VA research is an essential but under-publicized element of
the VA health care system. It has a distinguished history of
discovery and innovation that has benefitted veterans and the
Nation for over 90 years. The Congressionally authorized VA
affiliated non-profit corporations are proud to support and
augment VA research.
My name is Robin Rusconi. Since 2014, I have been the
executive director of the VA affiliated non-profit corporation
located in Kansas City, Missouri. I am currently the chair of
the Board of Directors for the National Association of
Veterans' Research and Education Foundations, known as NAVREF.
As a child of two World War II veterans, I am proud to be
supporting the VA research program and helping improve the
lives of veterans. NAVREF's mission is simple, we exist to
advance the success of the VA affiliated non-profit
corporations. I am here today to tell you about the great work
of our non-profits, our potential for greater contributions,
and the progress made since last year's hearing.
We are pleased that the House Veterans Affairs Committee
recognizes the importance of the non-profit corporations in the
VA research enterprise. Over the last four years alone, the
NPC's have administered over $1 billion in support of the
research and education activities at VA medical centers.
NAVREF and its members are excited too to support Dr.
Ramoni's three strategic priorities for VA research; to provide
greater access to clinical trials for veterans, to make VA data
a national resource, and to achieve substantial real-world
impact.
While NAV--excuse me--while NAVREF is proud of all the NPCs
have accomplished, we feel they have the potential to make even
greater contributions. In June 2017 the House Veterans Affairs
Oversight and Investigations Subcommittee held a hearing about
VA research that included testimony from NAVREF. During that
testimony, NAVREF made several recommendations. I would like to
update you on the progress made on two of those
recommendations.
First of all, we were heartened to hear that the Office of
Research and Development would engage an outside consultant to
assess the need for VA to establish and enforce clear
guidelines for administering Federal awards. Unfortunately, we
are frustrated that the process has moved slowly, and we are
concerned that the perspective of the non-profit corporation is
not being fully investigated and appreciated.
We believe the VA should enforce clear guidelines for the
administration of extramural research activities that offer the
NPC right of first refusal for all research efforts when the
majority of this work occurs physically within the VA.
Second, the VA's non-profit oversight board took several
positive steps last October regarding the oversight reviews
being conducted by the non-profit program office. Specifically,
the NPOB created a clear appeals process, established an
anonymous survey tool to receive feedback, and ensured
oversight review out briefs include the full board of directors
and the executive director of the non-profit corporation.
Each of these changes have been in place for a short time,
so it is too early to determine if they have been effectively
communicated to local VA leadership and if they will have their
intended impact. Additionally, we would like to see greater
clarity on the scope of these reviews. Our members are all
independent 501(c)3 corporations remain confused about what is
subject to VA review and what may be out of scope.
Thank you again for your attention to these matters. We
greatly appreciate your continuing support of the VA research
program and your support of the VA affiliated non-profit
corporations. We look forward to working with you to achieve
our vision of a Nation in which veterans receive the finest
care based on innovated research and education.
Mr. Dunn. Thank you very much, Ms. Rusconi.
Dr. Klotman, you are now recognized for five minutes.
STATEMENT OF PAUL KLOTMAN
Dr. Klotman. Thank you, Dr. Dunn. I really appreciate the
opportunity to testify in front of you today. In addition to
the Baylor College of Medicine, I also represent the
Association of American Medical Colleges, which is a non-profit
organization comprised of all the U.S. medical schools and
major teaching hospitals including many of the VA hospitals.
And I would like to thank the Full VA Committee for
preserving the VA's clinical relationship with academic
medicine in the VA mission act to ensure our Nation's veterans
have access to clinical services at our institutions and
receive the highest quality of health care.
For this hearing I will share information on the research
enterprise and the VA academic relationship through my
experience as a clinician and researcher. For you--you may not
know this, but I began my career as a trainee clinician
physician scientist at the VA, and I was also supported by the
NIH. I was a staff physician at the Durham VA for 13 years
while at the faculty at Duke Medical School. And both my wife
and I are partially supported by Duke to work at the Durham VA.
I have spent 17 years in civil service between my time at the
VA and the NIH. And, by the way, I am the Dean, my wife is also
the Dean at the Duke Medical School, we all started our careers
at the VA.
The Michael DeBakey VA Medical Center in Houston was the
first to affiliated with an academic partner, and has been
affiliated with Baylor since 1949. Today, it is one of the VA's
largest hospitals serving Harris County, Texas, in 27
surrounding counties.
Baylor physicians provide virtually 100 percent of the
medical care at the DeBakey VA. The veterans from around the
country are referred there, and Baylor physicians provide the
clinical services often not available by other providers, same
physicians at Baylor hospitals and the VA hospital.
Medical schools fully integrate research and education with
patient care, and these are very interdependent, as many of you
physicians know, and to split those apart would really
jeopardize the quality of care. Interestingly, the VA medical
centers share the same tripartite mission of education,
research, and clinical care. And by working together, we
enhance the care for veterans--research that provides new
treatments and train the next generation of health care
providers, many of whom are then attracted to have a career in
the VA.
Our clinical research partnership has led to tremendous
care for our Nation's veterans at the DeBakey VA. We have one
of the ten VA trans-aortic valve replacements programs, it is
only one of two in the country with expertise in bronchial
stenting for patients with lung cancer and fibrosis, and is one
of the few that has a designated stroke center.
The DeBakey VA is the hub of our VISN, but it also gets
national referrals with complex cases, second opinions, we have
people sent from all over the country to our VA. And we have
launch centers of excellence in cancer and Parkinson's Disease,
post-traumatic stress disorder, liver transplant, epilepsy,
substance abuse, and rehabilitation for mild to traumatic brain
injury.
Our faculty are absolutely passionate about improving
quality of care for the veterans, as well as our other
affiliated hospitals. As national leaders, they can rapidly
implement new guidelines and best practice initiatives for
medical conditions in the care of our veterans. This
partnership has played an important role in the DeBakey VA
achieving a four-star rating in just a six-month period of
time.
Research leads to medical advances, and Baylor and DeBakey
VA have supported collaborations leading to innovation in
mental health and cancer treatment, and prevention of
antibiotic resistant infections, and chronic obstruction lung
disease and emphysema, as well as cardiac care.
Nationally, most VA researchers have joint appointments at
the VA and the affiliated medical school, which to physician
scientists views it as a huge advantage, and it is a real
important recruiting tool. At DeBakey, VA researchers have
faculty appointment at Baylor giving them access to all the
resources at Baylor including core laboratory facilities,
oversight committees, dedicated IRB to the VA clinical trials,
accreditation for human and animal research, and pre-award
management for all non-VA grants. And these resources can be
prohibitively expensive for VA medical centers and their not-
for-profit corporations to support if they were independent of
the affiliate. Sharing with academic affiliates reduces
unnecessary redundances and maximizes the use of Federal
dollars.
Each VA academic partnership is unique. For example, about
20 years ago Baylor and the DeBakey VA consulted with the VA,
our non-for-profit organization, and HHS, and agreed that we
should be reimbursed by NIH grants for the on-campus facility
FNA. Baylor provides complete research oversight support and
provides annual contributions to the non-for-profit corporation
to support VA research. So money is flowing to the VA from us.
All other medical schools--at other medical schools, NIH
grants are administered via VA researchers vary based on the
amount of infrastructure provided by the VA. Due to this
variation in support that various VAs have for the research
enterprise, the AAMC believes that administration of NIH grants
should be determined at the local level by each VA medical
center. A one-size fits all approach could hurt VA research
programs as well as the collaborations with affiliates.
The DeBakey VA relationship with Baylor and the joint
appointment of researchers also is an important tool for
recruiting physicians and scientists to the VA and retaining
high quality researchers. The VA affiliation also enhances the
training quality of our programs, the Baylor programs. Our
students and residents have the opportunity to work with
veterans and learn about military health, which makes them
better doctors.
There are additional recommendations in the written
testimony, but if I leave you with one message today, it is
without the synergistic 70-year partnership with academic
medicine, the VA's ability to fulfil its mission of patient
care, education, research would be limited.
I appreciate this opportunity again, and I look forward to
answering any questions that you have.
Mr. Dunn. Thank you very much, Dr. Klotman.
Dr. Clancy, you are now recognized for five minutes.
STATEMENT OF CAROLYN CLANCY
Dr. Clancy. Good morning, Chairman Dunn, Chairman Bergman,
Ranking Members Brownley and Kuster, Members of the
Subcommittee. I appreciate the opportunity to discuss VA's
medical and prosthetic research program, and I am accompanied
by Dr. Rachel Ramoni our chief research and development
officer.
VA's Office of Research and Development has been improving
the lives of veterans through health care innovation and
discovery for more than 90 years. And in so doing, civilians
have also benefitted from groundbreaking advances including the
first successful liver transplant, and, as mentioned by the
Chairman, the pacemaker, and the first shingles vaccine.
We continue to conduct cutting-edge research such as the
development of a bionic ankle that helps propel users forward,
the creation of the Million Veteran Precision Medicine
Initiative, and groundbreaking work to repair severed spinal
cords. In addition to the scientific merit of VA research, VA
is also recognized for its ability to translate research
findings into real-world benefits for our veterans.
I want to thank the Committee for the additional resources
you provided in the omnibus. And, in fact, we have created a
one-page summary of how we will prioritize that unexpected but
very welcome investment of resources, which I would like to ask
be entered into the record.
Mr. Dunn. Without objection, it is entered.
Dr. Clancy. The non-profit research and education
corporations, or NPCs, are an important part of the VA research
partnership ecosystem, established in 1988 to serve as a
flexible vehicle to receive the external funds that help drive
VA innovation. For example, a recently announced multi-million-
dollar interagency agreement with the National Cancer Institute
will be administered by the not-for-profit corporations.
VA's affiliations with our Nation's medical schools go back
to 1946 when General Omar Bradley forged this pioneering
partnership. Seventy-two years later, we are affiliated with
well over 90 percent of medical and osteopathic schools, so
these partnerships give us access to cutting-edge technology,
expertise, and national research networks that would be
difficult, costly, and wasteful to duplicate within VA. For
example, the spinal cord repair program previously mentioned is
the product of a very strong collaboration with the University
of California system.
VA research is committed to supporting activities that
improve the health and well-being of our veterans. Our office
of research and development evaluates proposed research
projects by conducting rigorous scientific peer review.
Projects that are not veteran focused do not receive funding.
In addition, our research portfolio is continually
rebalanced over time to meet our veterans most pressing needs.
So, today, our five clinical priorities are post-traumatic
stress disorder, traumatic brain injury, suicide prevention,
opioids, and Gulf War illness.
While VA's medical and prosthetic research program focuses
on benefitting current and future veterans, the output of our
research ultimately benefits the Nation. For example, in 2017
VA launched a nationwide study of the health benefits of a
robotic exoskeleton for veterans with spinal cord injury. VA
research also has an impressive track record of transforming VA
health care by bringing new evidence-based treatments and
technologies into everyday clinical care.
Two key examples recently. First is the implementation of a
new suicide prevention clinical initiative, this has been
defused across our system. Based on predictive modeling and
existing medical record data to identify veterans at the very
highest risk of suicide so we can provide them with more
intensive services and follow-up.
Veterans are now using the bionic LUKE arm as the result of
our Office of Research's partnerships. The approval and
delivery to veterans of the most advanced prosthetic arm ever
created. This is an area upper limb prosthesis that has not
seen advances in about 50 years.
VA's medical and prosthetic and research program has
significantly improved the care and well-being of our veterans.
These gains have been possible because of consistent
congressional commitment in both the form of attention and
financial resources. And we believe it is critical to continue
to move forward with the current momentum and preserve the
gains made thus far.
This concludes my testimony. My colleague and I are
prepared to answer any questions.
Mr. Dunn. Thank you very much, Dr. Clancy.
We are going to take--go around the dais and have everybody
five minutes to ask you questions. I am going to ask the panel
to try to answer concisely. I know that it is hard sometimes,
we ask vague questions. But since we each only have five
minutes, it is a plus if we can be concise.
So I am going to yield myself five minutes now. And start
with Dr. Clancy a question. Given the prevalence of the PTSD
and TBI among veterans, I would like to know a little bit more
about this. These are prioritized treatments you have and
technologies, what do we--what can we offer our veterans that
we hadn't been offering?
Dr. Clancy. To some extent we are looking at different and
can offer now new medical treatments, and we are also looking
at ways of how to delivery those treatments. For example, I am
going to guess that you are aware that one-third of the
veterans we serve live in rural areas, so they have got a
pretty substantial distance to travel to get care. And we have
recently tested and developed a telehealth approach so that
veterans can get this care virtually. And as nearly as we can
tell from published studies, this is just as effective as
traveling that distance and coming in person.
Mr. Dunn. So you have got metrics on that?
Dr. Clancy. Yes.
Mr. Dunn. We would love to have you share that with us.
Dr. Clancy. Sure.
Mr. Dunn. Not right this minute, but that is something that
would be of keen interest, I think, to everybody in this
Committee.
Dr. Klotman, you mentioned not one size fits all, and one
of the areas that we have had some interactive with, which IRB
do we use?
Dr. Klotman. So it depends on what institution. In our
case, we have seven independent IRBs, but one of them is
dedicated to the VA. So we can get very quick IRB approval for
any clinical protocol.
Mr. Dunn. Is the VA IRB quick for you? Is it easy to use?
Dr. Klotman. It is because it is run by Baylor.
Mr. Dunn. Oh, okay.
Dr. Klotman. So we man--it is sort of outsourced to us, so
we do it for--
Mr. Dunn. Do you think that that translates across the
country to all the researchers, because we get the sense that
maybe it isn't?
Dr. Klotman. I would say one of the big problems, when
talking to academic institutions, with their VA affiliate is
getting clinical trials approved. And I think it would--it is
worth exploring how to improve the IRBs to facilitate clinical
research for veterans. Absolutely important.
Mr. Dunn. Okay. While I have got you there, Dr. Klotman, I
am going to ask you about translation of VA research to the vet
side. So that if a clinical translation, do you think that that
is happening well? Do you think it is happening rapidly, or
enough?
Dr. Klotman. I think it is happening terrifically well. We
respond, you know, scientists respond to funding opportunities.
When you list five priorities, our scientists are focused on
mental health, on opioid addiction, on PTSD, traumatic brain
injury. We are trying to do AI, run facial recognition to pick
up depression by tele-medicine. So we are very focused on
trying to translate our work directly to patient care. But that
is a mission, you know, of the--you look at the top 30 or 40
medical schools that are into research, it is--we do
translation research, that is what we are trying to do, and the
VA does it very well.
Mr. Dunn. So if I am a medical student--I am not going to
go back to medical school--if I was a medical student--
Dr. Klotman. I would feel sorry for you.
Mr. Dunn [continued]. --you could have a--you have a
syllabus for --and I think these three would fit--or four, top
four priorities, or five, would fit together very neatly; PTSD,
TBI, suicide, and opioids. I mean, that sounds like one
chapter, get this, and read it twice. Is that--we have a
syllabus for that?
Dr. Klotman. Well, we don't have a syllabus per se, but we
do encourage our students to do research with these
investigators. One of the--we have a specialized center called
iQuest, which is really around health and human services
research, it is one of the biggest in the country. And we have
25 faculty and probably 40 trainees in that group all doing
research appropriate for veterans. It is actually funded by the
VA and the NIH, and it is a tremendous center. So we have
direct access for our trainees and learners to get into issues
related to veterans.
Mr. Dunn. Great.
Dr. Clancy, so the same question on translation. Can you
address that from your point of view, or maybe Dr. Ramoni? You
choose.
Dr. Clancy. Well, research that we publish, and support is
highly publicized within our own system. The next step is
obviously to make sure that that is tightly linked with
clinical operations. And I have to say that under Dr. Ramoni's
leadership, there has been a much, much stronger partnership
there between the research enterprise and the people who have
got to worry every day about how to get this done.
We literally had all of our network leaders in town this
week, and to say--and Dr. Ramoni was not actually there for the
conversation--but to say they were excited about research, and
to hear where they have taken money out of their own budgets to
make sure that their veterans have access to the findings so
that they can put them into practice was quite--
Mr. Dunn. I am running short on time--
Dr. Clancy [continued]. --wonderful.
Mr. Dunn. --here, so I--and I want to be--I want to observe
the limits so that I will be a good role model here. The ORIEN,
Dr. Ramoni, are you using ORIEN for the total cancer care? Is
that something that is?
Dr. Ramoni. We are not--sorry--we are not yet participating
in ORIEN, and that is in part because ORIEN and APOLLO in which
we are participating, both are seeking the same types of
samples.
Mr. Dunn. Okay. You and I are going to talk offline. And I
recognize my time has run out. I will yield to Ms. Brownley.
Representative Brownley.
Dr. Ramoni. I look forward to that. Thank you.
Ms. Brownley. Thank you very much. I have just sort of a
general overall question as it relates to the research that VA
is undertaking. So where does one go to find out where all of
the research, you know, what are all of the research projects,
you know, across the country, and where is that happening? You
know, what are sort of the subject areas? Dr. Dunn just
mentioned a couple in terms of opioid abuse or brain injuries,
post-traumatic stress, et cetera. But where--I don't know kind
of what is happening on a global sense in terms of the
research.
Dr. Clancy. It is a great, great question, and I am so glad
you asked. We put out a lot of information in the form of
quarterly updates and newsletters. And I will tell you if you
run an organization, as I did for a number of years outside VA
that funds a lot of research, it is a bit challenging to figure
how do you put these into buckets together in a way that is
very, very accessible.
I think we could do a better job. I think that in many ways
some of the phenomenal research we are funding has become one
of the world's best kept secrets, and we are working very hard
to try to overcome that. Do you want to add to that?
We also have an external research advisory committee that
meets four times a year. So they become a very important source
of spreading our research. But we have a lot more to do.
Ms. Brownley. Are they like an overseer, or?
Dr. Clancy. They are an advisory group. I think it is fair
to say that they do give a lot of advice. And one person's
advice might feel like someone else's oversight. But four times
a year I think is a pretty good rhythm, and they are pretty
current on what is going on.
Dr. Ramoni. Hi. Thank you for your question. I would just
like to add that all of the research we fund is available
through ERA Commons, which is NIH reporter. So if you go to the
NIH reporter Web site and you select VA, you can get a list of
all the projects we fund.
Now, as Dr. Clancy said, I think we can do a better job of
summarizing that because I doubt with your busy schedules that
you have time to scroll through our 2,000 funded projects. But
what we are--what our national research advisory committee has
advised us is that we ought to, at least on a yearly basis,
summarize the research impact so that we can share more broadly
with others. And we do have a breakdown of where our funding is
going in terms of types of research that we can certainly make
available to you.
Ms. Brownley. And is that found on a Web site somewhere as
well in terms of the priorities and the amount of resources
funding as priorities?
Dr. Ramoni. We can certainly direct you to those. I am not
certain if they are listed on the Web site because as Dr.
Clancy said, it can sometimes be a challenge to clearly convey
the distinct categories. For instance, if you were looking at
suicide risk amongst people with opioid substance use disorder,
they would be classified under two sections. And so that is
sometimes a challenge for us to present. But we would be happy
to walk you through that orally as well in a briefing.
Ms. Brownley. Yeah. And just as a, you know, a layperson
looking into this, it seems--it just seems very complicated and
complex in trying to, you know, pull the layers apart to kind
of see what is there. And once you start doing that, it tends
to get more confusing--to me, anyway--and more complicated as
opposed to sort of understanding, you know, what are the broad
strokes, and are we all in agreement in terms of where--what
our priorities are in the areas in which we want to continue to
explore. And so, anyway, it just is a general statement. I
think for a layperson and for people to understand that we are
actually doing research and pursuing innovations when we really
can't translate to the public and to the communities so that
people know that their tax dollars are going to a good purpose,
and that we do want to resolve and solve some of these issues
that particularly veterans are experiencing when they come home
from the battlefield, so.
Dr. Clancy. So I am going to take that as a charge that we
need a greatest hits. To use an old analogy. No, but I mean, I
am saying that with the upmost respect. It takes some thought
and so forth to do that. But we should.
Ms. Brownley. Very good. I see my time is out, so I will
yield back.
Mr. Dunn. Thank you, Representative Brownley. And since you
yield back ten seconds, I am going to say we would all like to
see that list of, you know, sort of--not the all 2,000 but how
you are prioritizing, where the resources are going, and sort
of by subject matter what they are. So thank you very much for
that.
We will now recognize Mr. Poliquin for five minutes.
Mr. Poliquin. Thank you, Mr. Chairman, I appreciate it.
Thank you all very much. It is so important to make sure that
our research goes on with our affiliates, our academic
affiliates, in concert with VA to make sure that we do the best
we can for our veterans. We owe them that responsibility to do
that.
Dr. Klotman, I want to ask you a question. You mentioned a
minute ago some of your research dealt with diabetes, and what
have you. Why wouldn't the VA--why wouldn't all the research on
behalf of our veterans focus on ailments and maladies that are
specific to veterans like PTSD, and traumatic brain injury, and
exposure to toxins, and so forth, so on? If you have all these
other institutions around the country doing great work on
cancer and diabetes, why would we spend tax payer dollars to do
that when we can get that already?
Dr. Klotman. So I think you have to look at the broad
health of veterans throughout their entire life span. Yet there
are things that are very specific to veterans, but there are
also things that impact veterans' lives. If you look at, you
know, the vast number of veterans that we are taking care of,
their day-to-day problems are often common illnesses.
Mr. Poliquin. Yeah. We have research on most of those
common ailments.
Dr. Klotman. But breakthroughs come from all different
places. It is really hard to, you know, to say, well, we are
going to have a cure for diabetes that is NIH focused.
Mr. Poliquin. So we might be doing--
Dr. Klotman. Another big breakthrough might come from--
Mr. Poliquin [continued]. --we might be spending tax
payer--
Dr. Klotman [continued]. --VA--
Mr. Poliquin [continued]. --we might be spending tax payer
dollars working on diabetes for veterans where we are doing it
at other research facilities around the country, and you don't
think that is duplicative and wasteful?
Dr. Klotman. No, I actually don't. I will tell you the vast
majority of research that we do at the VA is very specific to
veterans' problems. But--
Mr. Poliquin. The veterans--thank you, sir. Dr. Clancy--
Dr. Klotman. Let me just say one thing, though. If you are
taking care of a veterans for their entire life span and you
are trying to have them have a, you know, good outcomes, you
have to take care of all of their illnesses.
Mr. Poliquin. No, of course not. I am not talking about
specific to a veteran, I am saying a malady that is specific to
the veteran population, that is what I am referring to.
Dr. Clancy, the VBA, the Veterans Benefit Administration,
collects mountains of data on the 7 million veterans we take
care of now. Do we aggregate this data, and whiteout, of
course, who the individuals are, but aggregate this data such
that we can use it to determine where the research should go?
Dr. Clancy. We have some people who are beginning to take a
very hard look at that. I guess--
Mr. Poliquin. Do we aggregate the data, and do we use it to
make decisions on where the research dollars should go for our
veterans? Because anybody that collects that amount of data on
the veterans certainly know what their problems are.
Dr. Clancy. Yes, and we are certainly aware of where the
greatest opportunities are in terms of--
Mr. Poliquin. Okay. So who is aggregating--
Dr. Clancy [continued]. --how many people apply for
benefits.
Mr. Poliquin. So who is aggregating that data?
Dr. Clancy. We can take that for the record, and I will
follow-up. It is not a routine function that feeds right into
research priorities, but I--which is what I think you are
suggesting.
Mr. Poliquin. If we are looking for research on veterans
who have problems, and we have mountains of data on what their
ailments are, it would make sense to me that we use that
information. So our office will get back to you to see what a
more complete answer would be, if that is okay.
Dr. Clancy. Yes, that would be fine.
Mr. Poliquin. Great. Thanks. Today, Mr. Chairman, there is
about $600 million in the VA budget that is specifically
earmarked for medical research that is conducted either at the
VA medical facilities around the country, about 160 of them,
but there is an additional $1.2 billion each year, roughly, for
veterans--for research for veteran health, and it comes mostly
from the NIH and the Department of Defense, and they are issued
by grants.
This research is either conducted at the VA or at medical
institutions, affiliates, academic institutions, universities
like Baylor, great universities like Baylor, across the
country. Now there are, if I understand this correctly--and,
Ms. Rusconi, you are going to correct me if I am wrong, I am
sure--there are roughly 150 individuals across the country that
make decisions where the administration of those research
projects go.
Either through you folks, through the NPCs, or they are
administered actually through the research organization
themselves. I think they are called investigators. And I think,
Ms. Ramoni, you came to us several months ago, and you used to
be an investigator. And, Mr. Klotman, you might be one now, I
don't know.
But my point being this. If an investigator is an employee
of the VA, and also an employee of say Harvard--my alma mater,
so I am not picking on Baylor--and they all of a sudden are an
individual, he or she, whose career is dependent upon how much
tax payer dollars they can come to that institution, whether
you are Baylor or Harvard, or Yale or Stanford, whatever it
might be, but they are also in a position to determine who gets
the administration dollars for that project. Now, up in Maine,
where I come from, that is a conflict of interest. And here is
why that matters.
Let's say you have a $10 million grant from the NIH. The
administration cost is an add-on to that grant. Now if I am not
mistaken, over at the NPCs that were formed 30 years ago
specifically for this reason, your add-on cost is roughly 25,
26 percent. So that is $2-and-a-half million on a $10 million
grant to develop whatever it might be, a new prosthetic.
However, now places like Harvard, my understanding--
Mr. Dunn. Mr. Poliquin.
Mr. Poliquin [continued]. --is that the add-on cost--
Mr. Dunn. Mr. Poliquin.
Mr. Poliquin [continued]. --is roughly 70 percent.
Mr. Dunn. Mr. Poliquin?
Mr. Poliquin. Yes, sir.
Mr. Dunn. Your time is expired, but I like your line of
questioning. I encourage you to pursue that.
Mr. Poliquin. Great. Would you like to, or anybody else
like to give their time to me? Mr. Chairman.
Mr. Dunn. I will give them their opportunity when your time
comes. All right. So that will be the next.
Mr. Poliquin. Thank you, sir.
Mr. Dunn. Representative Kuster, you are recognized for
five minutes.
Ms. Kuster. Thank you very much, Mr. Chairman, I appreciate
it. And thank you to all of our witnesses for being with us. I
want to also thank you for mentioning the LUKE arm in your
testimony, Dr. Clancy. We are very proud in New Hampshire of
the development of the LUKE arm, and I have had a chance to see
it in action, and it is really very impressive.
I wanted to hone in on the conversation about, our Chair
today has mentioned PTSD, traumatic brain injury, opioid
addiction. I am the Chair of a bipartisan task force in
Congress, we now have 105 Members working together, Republicans
and Democrats, on legislation to combat the opioid epidemic,
and I know that there is research being conducted, Congressman
Brownley referenced a study out of Minnesota. It would be very
helpful for us, and I would even like to ask our Chairs of the
Health Committee, and the Subcommittee, and the Oversight
Subcommittee, if we could put together a session that I would
be happy to organization with members from the task force to
talk about lessons that can be learned to reduce the use of
opioid medication.
But in that regard, can you talk a little bit more about
how this research is getting from the lab to use across the VA?
And then what we would like to do, I am working on legislation
about a center of excellence, so that we can then take those
lessons learned into the civilian population.
Dr. Clancy. So it is a great question, and, frankly, we use
any vehicle that we can. So, for example, in terms of treating
chronic pain and the use opioids, we have an evidence-base
guideline that we develop in collaboration with the Department
of Defense because it speaks to the unique injuries and
experiences of active duty members as well as veterans.
So that becomes one--because those guidelines are updated
almost continuously to make sure that they have all the current
evidence, that becomes one great vehicle to incorporate our
latest research. I think that your idea of having such a
session would be phenomenal because there is a lot going on in
three areas.
One is, what other alternatives do we have to opioids? A
second is, what nonpharmacologic in terms of chronic pain
management, which the whole country is struggling for, and a
bigger problem for our veterans. And the third is, how do we
help people who are addicted actually begin to return to a
functional life?
Ms. Kuster. And if I could just add to the list, a fourth
would be the CDC has recognized that four out of five heroin
users have co-occurring mental health issues--
Dr. Clancy. Yes.
Ms. Kuster [continued]. --and I think that veteran
population, with the anxiety, depression, traumatic brain
injury, we are finding in the civilian population trauma. For
example, sexual assault, domestic violence trauma. So I think
there is a lot to be learned, and you can tell from 105 Members
of Congress coming and working together right now, this is very
rare, and you can tell the urgency and the breadth of this
problem across the country. So love to work with you on that.
I guess my other question, I am very familiar, Dartmouth
Medical School is my district, I work a lot with them, and they
are the academic affiliate for White River Junction VA and
hope--we are working on an affiliation, hopefully, with our
Manchester VA that has had some troubles. I am familiar in the
private sector in the civilian world that we have, for example,
the New England Journal of Medicine, that physicians can stay
current on research that is published. Is there a corollary
from VA research where physicians can stay current based upon
research results that are published?
Dr. Clancy. So we have a terrific dissemination center that
is part of the Office of Research and Development, and they
will routinely put out surveys of research, which is--not
surveys, I am sorry, summaries of research that has just been
published and so forth which is extremely helpful, they will
usually give you the electronic link. So if the journal makes a
free access, right then you have got it. And I was literally
looking at one on the way over here.
Some of our work is also going to get into something at NIH
called Medline Plus, which actually translates into something
closer to plain language English, I don't want to over-state
this, sort of abstracts of published studies and so forth.
Whether we can and should do more, we share a lot of cutting-
edge findings with our veteran's service organizations and so
forth. But I am sure that there is more that we could do.
Ms. Kuster. So my time is, but I think I would join my
colleagues in saying that we would be very interested in
accessing those preferably plain English versions to understand
so that we can share with the tax payers the incredible
advances that are coming out of the VA. And I yield back.
Mr. Dunn. I thank you very much, Ms. Kuster.
Representative Higgins, we recognize you for five minutes.
Mr. Higgins. Thank you, Mr. Chairman. I would like to yield
a minute of my time to my colleague Mr. Poliquin.
Mr. Dunn. You are recognized.
Mr. Poliquin. Thank you, Mr. Higgins, very much, I
appreciate it.
We have already determined that at NPCs the add-on cost for
administration is roughly 25, 26 percent. Mr. Klotman, what is
the add-on cost of Baylor?
Dr. Klotman. 56.5 cents.
Mr. Poliquin. Say it again, sir.
Dr. Klotman. 56.5 cents.
Mr. Poliquin. 56.5. Ms. Rusconi, what is the difference
between the administrative functions you provide for research
down at the VA and the administrative that the folks at Baylor
do, or at Harvard, or Yale, or anybody else? Is the service
essentially the same? Does it include doing the paperwork, and
paying the bills, and ordering supplies? Do I have that right?
Ms. Rusconi. For the most part I would agree. At our VA,
our VA actually has--takes care of all of the RIB and all of
the services that were described.
Mr. Poliquin. Thank you. Mr. Klotman, who determines
whether it is 56 percent or 70 percent?
Dr. Klotman. The NIH. The NIH comes--the HSS comes and does
a very complete audit, which it is like everything--
Mr. Poliquin. So it is NIH?
Dr. Klotman. Yes, it does.
Mr. Poliquin. Whoever awards the grant, they determine what
you are going to get paid?
Dr. Klotman. We negotiate with them every three years, and
we show our costs. I mean, it is very rigorously reviewed, the
costs of oversight and research. The differences are often what
services you are providing. So we, you know, we provide IACUC,
IRB, all those real--those are real costs that--
Mr. Poliquin. Ms. Rusconi, do you provide the same services
they do at the academic affiliates?
Ms. Rusconi. Actually, at the Kansas City VA we provide the
IACUC, the IRB, and the R&D for our facility as well as the
facility in Wichita, Kansas, and we provide--
Mr. Poliquin. Okay.
Ms. Rusconi [continued]. --the IRB--
Mr. Poliquin. Okay.
Ms. Rusconi [continued]. --and for--
Mr. Poliquin. Thank you. We are stewards of the tax payer
dollars, we are $21 trillion in debt, the interest payments on
that debt are about $240 billion a year, that exceeds our
entire budget by the VA by about 40 percent. Every dollar
counts.
Mr. Dunn. Mr. Poliquin.
Mr. Poliquin. What I am trying to determine is, we have got
two folks--
Mr. Dunn. Mr. Higgins--
Mr. Poliquin [continued]. --providing the same service--
Mr. Dunn [continued]. --will you yield another minute--
Mr. Poliquin [continued]. --but one is--
Mr. Dunn [continued]. --to Mr. Poliquin?
Mr. Poliquin [continued]. --twice the cost of the other,
and I am trying to figure out why.
Mr. Higgins. I already have.
Mr. Poliquin. Sorry, Clay. Thank you, Clay.
Mr. Dunn. One more minute.
Dr. Klotman. I would just say, you should look at the
services provided. I mean, this is a real menu of costs, these
are not fictitious costs, they are real overhead. Just in the
same way you come to this building--
Mr. Poliquin. And whoever issues the grant, NIH DoD, they
determine what your costs will be in negotiate with you,
correct?
Dr. Klotman. Correct.
Mr. Poliquin. Okay.
Dr. Klotman. And the grants--a point you made before about,
it is the individual and the conflict of interest. The grants
are administered to the institution not to the individual.
Mr. Poliquin. No, but the individual--
Dr. Klotman. It is in the name of the institution.
Mr. Poliquin [continued]. --who's the investigator at the
institution can also award the administration to you.
Dr. Klotman. The--
Mr. Poliquin. Is that correct?
Dr. Klotman. Well, that is not really accurate. For NIH it
is the grant is awarded to the institution on behalf of the
individual. The expectation is that the institution supervises
and oversees the research, and that the spending is responsible
within--
Mr. Poliquin. And who determines where that
administration--administrative dollars go? Does the NIH or does
the investigator?
Dr. Klotman. The NIH determines where it goes, it is not
the individual investigator. With an individual--
Mr. Poliquin. That is not what Dr. Clancy and Dr. Ramoni
told me.
Dr. Klotman. No, if there is an individual who has shared
time, every two weeks they have to fill out their activities
report, and if--the amount of time that is covered at the VA is
covered by the VA, and the amount of time that is covered by
the NIH is covered by the NIH. There is no overlap of the two.
Mr. Poliquin. Okay. So you don't think it is a--
Mr. Dunn. One moment, Mr. Poliquin. Representative Higgins,
you have three minutes remaining. Do you--
Mr. Higgins. (Inaudible).
Mr. Dunn. Then you are recognized for three minutes,
Representative Higgins.
Mr. Higgins. Thank you, Mr. Chairman. And God bless you my
colleague, Bruce.
Dr. Clancy, you may recall, madam, we met in my office, and
we briefly discussed inclusion of urgent care facilities as a
means by which veterans could access care in their community.
The VA mission act passed the House of Representatives
yesterday. If signed into law, will this provision and the
precedence set by the recent launch of urgent care access for
veterans in Southern California, will that provide the VA
adequate authority to expand access to these walk-in urgent
care facilities in other regions? I have been advised that it
would. Thank you for that answer.
Dr. Clancy. Yes.
Mr. Higgins. My larger question to you, Dr. Klotman, you
mentioned some of the research being tele-medicine using facial
recognition for depression. I have an overall concern about a
culture of over prescription, of pharmaceuticals, for our
veterans; opioids, anti-depressants. And when investing money
that has been harvested from the people to pay for research,
and I am a big supporter of tele-medicine, I think it is
wonderful, I have large rural communities in my district, but
facial recognition for depression, how would that determine the
difference between temporary depression or normal moments of
sadness, or reflection, a contemplative somber moment, how
would that differentiate from the diagnosis of clinical
depression which could lead to further over prescription of
pharmaceuticals into our veterans population? I am very
concerned--
Dr. Klotman. No, I understand.
Mr. Higgins [continued]. --about the culture we have
created within our veteran populations that our goal should be
to get them back into a state of productive--
Dr. Klotman. I agree.
Mr. Higgins [continued]. --participation in society, and
yet we are building barriers for them to return to work, and
return to society, as a productive citizen because of the
pharmaceuticals that we prescribe.
Dr. Klotman. Well, I think you have hit upon a national
problem, you are absolutely right. The study that is currently
ongoing is to do exactly what you said, can you sort out a
situational--
Mr. Higgins. Are we working on non-medicinal treatment--
Dr. Klotman. Oh, yeah.
Mr. Higgins [continued]. --research for PTSD, for instance?
Dr. Klotman. Absolutely. Absolutely, yeah.
Mr. Higgins. Service dogs--
Dr. Klotman. And the other thing--
Mr. Higgins [continued]. --exercise, group therapy, et
cetera?
Dr. Klotman. And it is hard for veterans sometimes to come
to the VA. The whole purpose of this is getting more continuous
follow-up so you can detect problems sooner. I mean, the idea
is to improve their lives in ways that are not drug dependent.
Absolutely.
Mr. Higgins. Thank you for your answer. And I would also
like response, perhaps in writing, from my colleague brought
up, Mr. Chairman, regarding where exactly can we observe what
research is taking place across the country and what the nature
of that research is. I yield back.
Mr. Dunn. Your question is noted, Representative Higgins.
Representative Lamb, you are recognized for five minutes.
Mr. Lamb. Thank you, Mr. Chairman.
Dr. Clancy, by way of greatest hits, I just wanted to note
back in Pittsburgh in a VA that is not actually in my district,
but it is near it, and it takes care of many of veterans from
our district, we had the development of a pneumatic wheelchair
powered by an air motor, Dr. Rory Cooper, we are very proud of
that.
The chair only weighs 80 pounds, and it can be used--it is
waterproof basically. So one of the things they have used it
for is kids with disabilities go to water parks and they use
it, veterans as well. So that was a great achievement by our VA
research in Pittsburgh at the human engineering research lab.
So I think that is a good one to highlight. It has made a big
difference in people's lives. It is easier for family members
to carry it around because it is so light.
One concern that I have heard expressed from folks back in
Pittsburgh is that in the Office of Research and Development,
there tends to be a lot of resources behind the research side
of it and less behind the development side of it. So I will
just throw it open, maybe either Dr. Clancy or Dr. Ramoni, have
you heard that concern before from people within the system?
Dr. Ramoni. Thank you, Congressman Lamb. That is, as you
heard, one of my three priorities is to increase the real-world
impact of VA research. And, in fact, in collaboration with Dr.
Rory Cooper's lab in Pittsburgh, and I had the pleasure of
visiting it and using that pneumatic wheelchair which is really
a remarkable invention, we are establishing a development
pipeline with him.
Often the first step is producing enough of a thing such
that you can get buy in to produce it more broadly. For
instance, to have enough versions of that pneumatic wheelchair
such that a company might want to pick it up and produce it and
distribute it. So we are entering currently into a partnership
with Dr. Cooper's lab in order to do that.
In addition, we are taking a number of other steps to
ensure that we move from bench or lab to bedside more quickly.
We are, in the basic science space, funding actual development
dollars to conduct toxicology studies which are the gap between
the bench research and moving into clinical trials. So we have
a broad-based effort to take more of our in-lab developed
innovations and move them out where veterans can benefit from
them.
Mr. Lamb. What is kind of the number one thing that we can
do to support that to make it easier?
Dr. Ramoni. Well, it is certainly companies--I would say
one of our great challenges is that sometimes veterans have
very specialized needs. And so, for instance, an upper limb
prosthesis, some companies might not find it financially
attractive to proceed in those spaces. And so any help that,
frankly, and party can provide to us in helping to overcome
that barrier would be wonderful.
As an alternative, we are looking at, in those cases, could
we as a department, and obviously this would be outside of
research and development, could we actually produce those items
for our veterans if no for-profit company is willing to step
into that space.
Mr. Lamb. In addition to just overall more funding for
research, are there specific programs that could use a shot in
the arm to improve that transition that you are talking about?
Dr. Ramoni. So in technology transfer, and, of course,
people know a GAO report came out recently, and that is an area
of intense focus for us, we are doing a fantastic job on
getting invention disclosures. The machinery to then actually
market those inventions to producers is something that we are
building. And so that area in particular will help us go from
invention to actual real-world use by veterans.
Mr. Lamb. Great. And I yield back the remainder of my time,
Mr. Chairman. Thank you.
Mr. Dunn. Thank you very much, Mr. Lamb.
Mr. Arrington, you are recognized for five minutes.
Mr. Arrington. Thank you, Mr. Chairman.
I want to follow along the line of my colleague Mr. Lamb. I
was former vice chancellor for research and technology
commercialization at Texas Tech, believe it or not. It is
complicated, and it is challenging to get an early-stage
technology to market. It takes a lot of time, it takes a lot of
capital, it takes an entrepreneurial team. Not many
universities are culturally aligned with sort of this sort of
entrepreneurial dynamics that exist in the marketplace. So you
got to really wire it well. There are some sophisticated
ecosystems at Stanford, and Boston, and some other places, but
it is very, very difficult.
Personally, my take on this is get it out, get it out of
the VA, for God's sake. And I am just saying that because it is
a big bureaucracy, and it is not entrepreneurial or innovative,
but there could be some great discovers. I think relatively
speaking, it is just universities don't have that very well.
The best way to commercialize it is get it to a start-up
company, get it to an established industry partner and let them
run with it, and make sure that we take a piece of the action
to evergreen the research.
Speaking of that, what are the deals that we made? How
many--you said disclosures have increase, so what about revenue
from--what about license agreements? Are they going up or down?
Sorry, you, Ms. Ramoni.
Dr. Ramoni. Rachel. Yes. So thank you for your question. It
is an area that is a very high interest to me not only for the
revenues but also because this means that these products are
out there where veterans can benefit--
Mr. Arrington. Exactly.
Dr. Ramoni [continued]. --from them.
Mr. Arrington. But if there is no financial motive they
won't do it. Just let's be clear.
Dr. Ramoni. Absolutely.
Mr. Arrington. So how many license agreements? Are they
going up or down, or are they flat?
Dr. Ramoni. They are going up. And I have the facts and
figures in here. But I can tell you, in terms of royalties, and
if you read the GAO report, it is a pretty stark description of
where we are now, or where we were. Back in 2016, we just had
$300,000 in royalties. And I have to say, historically that--
Mr. Arrington. 300, how much?
Dr. Ramoni. Thousand dollars in royalties.
Mr. Arrington. That is it?
Dr. Ramoni. Yes. And that is what I am saying. It is a
pretty stark--
Mr. Arrington. How many annual disclosures do you get of
potential IP--
Dr. Ramoni. We get hundreds--
Mr. Arrington [continued]. --potential marketable product?
Dr. Ramoni. Over 500 disclosures.
Mr. Arrington. Over 500?
Dr. Ramoni. That is right.
Mr. Arrington. So I would say that is--
Dr. Ramoni. Yes. And I do want to add that--
Mr. Arrington. How long have you been in this space of
technology transfer within the VA?
Dr. Ramoni. Well, I have just been--
Mr. Arrington. Not you personally, the VA in general.
Dr. Ramoni. So the VA, I think the--certainly the attention
that the VA receive from the House Veterans Affairs Committee
surrounding the Shanaze hepatitis C treatment brought greater
attention, and we are grateful for Mr. Bergman having written
to the Secretary to increase our number of staff in tech
transfer. So it has been a relatively recent growth in our tech
transfer team, and we got a new head of tech transfer--
Mr. Arrington. I would outsource it.
Ms. Ramoni [continued]. --tech transfer team.
Mr. Arrington. I would give it to a group that does that,
that that is their core competency. They do that for a living.
They have the connections with the money guys. They have the
connections with the industry. They move at the speed of
business. I just would do it.
I mean, I must say, 500 disclosures--
Ms. Ramoni. Yes.
Mr. Arrington [continued]. --and $300,000 in revenue--
Ms. Ramoni. Yeah, I know.
Mr. Arrington [continued]. --is paltry.
Ms. Ramoni. I--
Mr. Arrington. And it is--I am not blaming you. I just
don't think it is aligned with the core mission.
Ms. Ramoni. Well--
Mr. Arrington. We have got to have incentives to get
these--this IP to--into the right hands, where they can raise
the capital, take it to market, and make a difference. They
will never make a difference, in my opinion, inside the VA
culture. It is not wired for that. And it is--
Ms. Ramoni. Right.
Mr. Arrington [continued]. --not an indictment on your
skills and competency. It is just a culture reality.
Ms. Ramoni. I agree with you--
Mr. Arrington. What is the--
Ms. Ramoni [continued]. --entirely.
Mr. Arrington [continued]. --let me just jump to Clancy--
for
Dr. Clancy. What do you--how do you measure success? And I
am not trying to be rude. I just--it is time. We don't have a
lot of time. So what--how do you measure success among your--
the researchers that you give taxpayer money to, to discover?
Dr. Clancy. Sure. So broadly, that would be publications,
of course. It would be who else or what other entities have
picked up those publications. So for example, if work published
becomes part of a Medicare quality measure, that is going to
have a big impact--
Mr. Arrington. Does--
Dr. Clancy [continued]. --and get out and so forth.
Mr. Arrington [continued]. --transferring the technology,
to commercializing the technology, is that a metric?
Dr. Clancy. That has to be a metric.
Mr. Arrington. Is it a metric of success? Do you--
Dr. Clancy. Yes, yes.
Mr. Arrington [continued]. --hold people accountable for
that?
Dr. Clancy. Do we hold them accountable? Not yet. I want to
be clear. Under Rachel's leadership, just in the past two
years, we are on an upward curved for sure. I would love to
have the opportunity to follow up with you, your staff, about
what might be some options for who else we could partner with
to make this happen. Some parts of the government have small
business innovation research, and a variety of mechanisms that
we actually do not have.
But that is just one that occurs to the top of my brain. I
am sure there is a variety of other mechanisms, and given your
experience, I think it would be a great--
Mr. Arrington. I would love to--
Dr. Clancy [continued]. --opportunity to follow up on.
Mr. Arrington [continued]. --sit down with you. I want it
to be successful, and I am over my time.
If you have a second round, I am going to stick around.
Mr. Dunn. And to that point, we will have time for a second
round. I encourage you to stick around and take advantage of
that.
Mr. Arrington. Thank you, Mr. Chairman.
Mr. Dunn. These are great questions.
Mr. Arrington. Sorry to abuse my--
Mr. Dunn. But I will recognize now, for five minutes,
Representative Rice.
Ms. Rice. Thank you, Mr. Chairman. The Vietnam Veterans of
America's statement for the record raised an issue about
limited VA funded research for certain health conditions that
are of immediate consequence to veterans, citing the long-term
effects of Agent Orange exposure as an example. That remains
significant for Vietnam war veterans. And conditions stemming
from military exposure, such as toxic substances from burn pits
for Iraq and Afghanistan veterans.
This point relates to an issue that has been raised by
veterans in my district, in New York, on Long Island, regarding
exposure to liver fluke in Vietnam which is a parasite
prevalent in Southeast Asia known to cause a certain type of
cancer that can take, literally, decades for--I mean, I am
telling you. You guys know this--for symptoms to appear.
The VAMC in Northport, which is further out on Long Island,
conducted the first ever pilot study on liver fluke in Vietnam
vets through a partnership with an academic medical center in
South Korea, which was privately funded after the VA declined
to fund the study. For veterans who are just starting to show
the long-term effects of something that they were exposed to in
Vietnam, this type of health condition, obviously, is of
immediate concern.
So to any of the panel Members, this concern that the VA is
not funding research for certain health issues that are of
immediate consequence to veterans--and now, while I may admit
that this--the effects of liver fluke might relate to a small
population of veterans, they still served this country, and are
suffering this condition because of their service.
So if anyone can answer that question as to why the VA is
not funding research for certain health issues that are, right
now--and for that matter, the Iraq and Afghanistan veterans,
that are of immediate consequence to veterans?
Dr. Clancy. Well, thanks to your support--that is of the
Congress, right? We are funding a burn pits registry, and I
have been really seriously impressed by the enthusiastic
response from veterans in terms of their enrolling in this. And
one of Dr. Ramoni's five priority areas for the additional
support we got through the omnibus is actually to focus on
exposure to Agent Organ and the impacts among Blue Water Navy
veterans.
The liver fluke issue is quite interesting. I would say it
is fair to say that one can find lots of examples, not just at
VA but elsewhere, where somebody turned down a very novel, kind
of, research product at one point in time or in--what was
something that in--overtime turned out to be very, very
consequential.
The word is out among veterans. One of the challenges we
have is that we do not, at this moment in time, as I understand
it, have a commercially available test to be able to test for
that. So many veterans are coming in to see their docs, saying
``I want this test because I read about this research.'' So we
need to find out more about that, and we would be happy to
follow up with you.
Ms. Rice. Well, thank you. I would ask--
Dr. Clancy. And I know that Rick is very interested.
Ms. Rice. Yes, thank you. Final question, then I will give
whatever time I have to Mr. Poliquin, if he wants it.
What steps can the VA take to standardize and eliminate
delays associated with the ISO reviews, to advance clinical
trials, and support successful research partnerships?
Dr. Clancy. ISO with you.
Ms. Ramoni. Thank you for your question. As you might have
heard, we held a summit on April 12th with a broad variety of
stake holders to look at all the barriers that prevent us from
starting up clinical trials, especially industry trials,
efficiently.
One of those was the information security officer review,
and I am very happy and proud to say that we now have three
research specific information security offers--officers in
place, and I have been receiving e-mails from the field that
say that this transforms everything, and this, when we
announced it at the summit, received a standing ovation. So
Ms. Rice. Well, that is great.
Ms. Ramoni. --we are pleased to have addressed that.
Ms. Rice. Great, great. That is great news. And I have 51
seconds for my friend Mr. Poliquin--
Mr. Poliquin. Thank you.
Ms. Rice [continued]. --with the Chairman's approval.
Mr. Dunn. You are recognized for 46 seconds.
Mr. Poliquin. Thank you very much, Congressman. I have in
front of me the May report of the Inspector General at HHS. Let
me read this to you, if I may.
``The Department of Health and Human Services, which is the
parent organization for the National Institute of Health, and
under that is the Division of Financial Advisory Service, DFAS,
is the Federal agency responsible for negotiating and
establishing indirect cost rates, i.e. administrative rates,
for non-profit organizations, our affiliates, academic
affiliates, that receive the majority of the Federal awards
from HHS.'' And their conclusion in part, ``DFAS did not always
comply with Federal requirements for establishing indirect cost
rates.''
So I am very suspect that the process that is used to
determine the rates between our affiliates in the Federal
government is up to snuff. But with that, thank you very much
Congressman Rice. I know we are going to have a second round,
if I am not mistaken, Mr. Chairman.
Mr. Dunn. There will be a second round.
Mr. Poliquin. Thank you.
Mr. Dunn. I now recognize General Bergman for five minutes.
Mr. Bergman. Thank you, Mr. Chairman. You know, we are
overloaded with acronyms around here. We would like to give you
a new one; RTR, Research to Results.
So having said that, as you look at where you are, because
we see--I see a lot of familiar faces at the testimony table,
and you see at the front end of the food chain with those doing
the research, we see you all the time. Why don't we see them?
That is okay. It is a rhetorical question. I can tell, stunned.
No, the point is the--we have all played the game where you
start the message around the room and by the time it gets
back--and this Committee, you know, bipartisan, we want to get
to the bottom line very quickly. Not that they have to come
here and testify, but I would suggest to you that most of the
Committee Members here would be more than willing to devote
some time to walk right into a research lab because of the fact
that we get to talk with the people right then, right there.
So when front end, those literally in the labs doing the
research, to this end where we are doing, you know, the
testimony if you will, as far as the results--again, I will
just speak for myself. I like to see the amount of layers that
this goes through, and where it gets scrubbed, where it gets,
you know, redirected. So the point is, we can do better.
Dr. Clancy, do you think the VA, NIH, and possibly DoD are
duplicating research?
Dr. Clancy. Having run a research agency for a number of
years, for HHS, I can assure that a very key part of all
applications submissions is saying where else that you are
funded, and if you are untruthful about that, that is fraud and
a reason to withdraw support. So by and large--and we have
people that check that all the time. So I don't think that they
are duplicating research.
What I worry about more is gaps, and that is where we have
been reaching recently far more to the NIH, to Defense, and so
forth, to figure out ``Okay. Here is all this great stuff''--
Mr. Bergman. So the point is--
Dr. Clancy. Yes.
Mr. Bergman [continued]. --if we were to say, ``Okay. Can
you give us an example over the last four or five years of
where a--this review board or whoever the folks were, you could
produce a list of said, ``Okay? You know, Houston and New York
are doing this overlap, and we said no to one of them.'' I
mean, is there some kind of data that we could get?
Dr. Clancy. In general, that is almost always going to be
handled before it even gets to peer review by a scientific
committee. If it doesn't get handled then, it is going to get
handled before--
Mr. Bergman. Are there records? I mean, of the peer--I
mean, the bottom line is, when someone is sitting at a desk, is
asked to look at a couple different proposals and says, ``No,
we are already doing it here,'' is there data that we can pull
up that says that?
Dr. Clancy. If it looks--I can't speak for NIH, but could
find out for you, and I don't know if we have that kind of
record. I know that in general, we feel like the opportunities
greatly exceed available resources, which is not intended to
sound ungrateful. But it also means that--
Mr. Bergman. Well, that--but that is more of a reason--
Dr. Clancy. Exactly.
Mr. Bergman [continued]. --because if you have more
opportunities than you do have resources, we have to ensure
everything--
Dr. Clancy. Yes.
Mr. Bergman [continued]. --we do does not accidently
overlap something that is already being done, because we are
dealing with finite resources here that we have to focus on
that research that is going to directly benefit our veterans in
the long term.
I would like to, just for a second here, to expand on Mr.
Poliquin's line of questioning. You know, Dr. Clancy, in many
instances, a researcher who decides which entity, the VA or the
affiliate, will administer the NIH or DoD grants. Do you think
allowing the researcher to make the decision creates a conflict
of interest? And if so, what can the VA do to eliminate that?
Dr. Clancy. I think that it may be perceived as a conflict
of interest, which the distinction between those two, I think,
is negligible. At--
Mr. Bergman. A lot of cases, they have dual appointments.
Do you think there is any pressure being put on, in some cases,
because you have a dual appointment? You are basically working
very hard, but you can only serve one master, but you might be
serving two.
Dr. Clancy. Whether people perceive that there is implicit
pressure, for example in the form of promotions and tenure and
things like that, I can't say. I think the study we are doing
now will shed some light on that in terms of how those
decisions are made.
Mr. Bergman. When do you think that study will be done?
Dr. Clancy. Rachel? When will the WESTAT study be done?
Ms. Ramoni. The WESTAT study will be complete by the end of
September, sir.
Mr. Bergman. Great. I look forward to that. And I am going
to give you back ten seconds, Mr. Chairman.
Mr. Dunn. Thank you very much, General Bergman. So we have
finished the first round of questions. We are blessed to have
some time left on the clock. We would like to go about around
and allow additional questions. So in--clearly, there are
passionate and interested people here on the dais.
Representative Brownley, I recognize you for five minutes.
Ms. Brownley. Thank you. Dr. Clancy, I wanted to ask you a
question. Congress authorized two major medical leases at Heinz
and Albuquerque focused on research activities. To date,
neither lease appears to have been executed by the department,
and in fact, VA has told stake holders that it is engaged in
procuring a contract to re-examine the requirements for the
Heinz location.
This is concerning because Heinz researchers are located,
my understanding, in a century-old building. Additionally, in
this year's President's Budget Submission, VA removed a request
for a lease for a research facility in San Francisco. I am
concerned that VA is not taking action to ensure that VA
researchers and partners have access to modern facilities to
conduct research which we know is a major plus in VA for
recruiting clinicians.
Can you tell me what the status of the three leases, and
what assistance you might need from Congress to move forward on
these leases for which you clearly identified a need as
recently as a year ago?
Dr. Clancy. I will take that for the record and get back to
you promptly. I don't know the status of the current leases. I
do know that the San Francisco VA is now engaged in a
partnership to move major chunks of their facility. So I can
imagine that might have led to a delay or pause in the
additional research space, but for Heinz and Albuquerque, I do
not know.
I do note to Mr. Poliquin and the Chairman Bergman's
questions that some of the issues around space and available
research space have something to do, I believe, with where the
indirect costs are actually administered on occasion. But we
will get--
Ms. Brownley. If you could get back--
Dr. Clancy. Of course.
Ms. Brownley [continued]. --to me on that, I would
appreciate it very much.
And Dr. Klotman, in your testimony, you said ``To duplicate
services such as numerous oversight and review services, if NIH
grants were to instead be managed by the NPC, would produce no
additional value and be a wasteful use of tax dollars.'' Can
you expound on that?
Mr. Klotman. Well, I think it depends and, again, each
institution is a little bit different. We do--and in part
because we were--we have this long relationship with the VA
dating back to the, you know, mid-40s. A lot of the research
infrastructure was generated on the Baylor College of Medicine
side.
If, for some reason now, it was, ``Well, let's have it all
administered by the not-for-profit entity,'' they would have to
duplicate a lot of things that we are doing. They would have
to--the Oversight Committees, the IRB, everything, including
bringing on and recruiting faculty, and educating them as to,
you know, ethical conduct of research. There is just a lot
infrastructure that would have to be duplicated to do that, and
that is why I think it is duplicative in our case, but not in
all cases.
Ms. Brownley. Yeah.
Mr. Klotman. But in our case.
Ms. Brownley. Ms. Rusconi, do you--would you like to
comment?
Ms. Rusconi. Yes, I would really like to respond to that. I
applaud what they have going on down at Baylor. We absolutely
would not ever want to upset a system that from all appearances
is working very, very well, both for the VA, the non-profit,
and for the affiliate. There is no reason to change that, but
there are many, many other situations throughout the country
where that is not happening, and that is part of our concern.
There are also other models besides what is happening at
Baylor, like in California, where some of those services are
split between the VA and the affiliate, and also where there is
a different format for the submission of grants. If the
predominance of the work is occurring at the VA, then the non-
profit takes the lead. If the predominance of the work is
taking place at the affiliate, then the affiliate takes the
lead.
And that has worked out very well, and honestly, the most
profitable--for the most part, the most profitable NPCs are
actually on the West Coast and they benefit greatly from that,
and their VAs benefit greatly from that. For instance, they get
infrastructure and many other things, like buildings and all
those other pieces that the non-profit can contribute to that
VA.
Ms. Brownley. Thank you for that, and I yield back.
Mr. Dunn. Thank you, Representative Brownley.
Representative Poliquin, you are recognized for five minutes.
Mr. Poliquin. Thank you very much, Mr. Chairman. Ms.
Rusconi, if the NPC in your case is awarded the administrative
work for research done at the VA, if you don't use all those
dollars in the administration of that project, does that go
back to the VA?
Ms. Rusconi. I don't think I understand the question.
Mr. Poliquin. If in the administration of the project or
the project itself, the research project itself, if all the
funds are not consumed for that project, where does the money
go?
Ms. Rusconi. If it is a Federal project, the way that it is
done is we--the administrative body, whoever it is, whether--
Mr. Poliquin. Yeah.
Ms. Rusconi [continued]. --it would be the affiliate or the
NPC, they have to expend those costs first before they get
reimbursed. And so we would not be able to draw down those
funds. So that is--
Mr. Poliquin. So it stays in the VA?
Ms. Rusconi. Well, it doesn't go to the VA. It would never
leave the NIH. So if we had a researcher that had $50,000
grant--
Mr. Poliquin. Okay. Thank you.
Ms. Rusconi [continued]. --that is what would happen, but
if--
Mr. Poliquin. Thank you. Dr. Clancy--and I don't want to be
rude, Ms. Rusoni. We just have a limited amount of time.
Dr. Clancy, if Harvard--to pick on Harvard a little bit, my
Alma Mater. They are a great school. If they win a--they apply
for and receive a $10 million grant from the NIH, they receive
the money, they are doing the research, and they don't--and
also, the investigator is working for the VA and for Harvard.
So the investigator says, ``No, we are going to do the
administration also,'' which I think is an inherent conflict of
interest. We have already discussed. Is that if--and that is--
and their markup, I guess, is 70 percent. So you are talking
about $10 million for the research, $7 million for the add-on,
administrative add-on.
If that money in either case is not used, does Harvard keep
it? If the research project ends without spending the $10
million, do they keep it, or do they return it to the VA, or to
the NIH?
Dr. Clancy. They do not keep it. I--
Mr. Poliquin. Where does it go?
Dr. Clancy [continued]. --don't believe they return it.
Mr. Poliquin. They just don't draw it down; is that
correct?
Ms. Ramoni. They do not draw it down--
Mr. Poliquin. Got it.
Ms. Ramoni [continued]. --Mr. Poliquin.
Mr. Poliquin. Thank you very much.
Ms. Ramoni. Also, I would like to point out that the off-
site rate--so if the work were being done at the VA but run
through Harvard, the off-site rate for that typically is around
20 percent, 25 percent. So pretty close to that of the NPC.
Mr. Poliquin. Ms. Rusconi?
Ms. Rusconi. My question, when they are talking about the
off-site rate for the affiliate, is if that work is happening
at the VA, why would they be getting an indirect rate at that
point? Because honestly, at that point, if the work is
happening at the VA, there should be a subaward to the NPC.
Mr. Poliquin. You know what I would like to see? And I am
going--we have subpoena power here, don't we?
Mr. Chairman? We have subpoena power here, don't we? Yeah,
great. Okay. Here is what I would like to see.
It is going to be very simple, and I think I asked for it
last time Dr. Clancy and Dr. Ramoni were here. It is very
simply. What I would like to see is going back--take five
years. We could probably go back 50, but let's take five years.
What I would like to see is every grant that was awarded by
the VA, by the NIH, by the DoD, and any other large
organizations that do that outside the VA. I think it is the
NIH and DoD. Every grant, what it was used for, who it went to,
what the amount was for, who did the administrative work, and
what that amounted to? That would be really tell-tale. So we
can see--and what--so we can determine what the rate is. So we
can see where the taxpayer dollars are going.
This is supposed to be used for care of veterans. I am all
for research. I love it. I want to make sure the taxpayers
aren't getting ripped off, and I want to make sure that our
veterans get maximum bang for their buck. And when you have a
delta between 25 percent and 56 percent, or 70 percent, which
was what was told last time, last July, if I understand this
correctly, then something is wrong. I am missing something.
And so I want to get that data. So Dr. Clancy, how do we
get that data?
Dr. Clancy. We will take a first crack at assembling it for
you.
Mr. Poliquin. No, we already have a study that we went--we
started back in July or September, whatever it was, we are six-
or nine-months in. It will be a year before we get the study.
Is it going to have this data?
Dr. Clancy. Rachel?
Ms. Ramoni. Mr. Poliquin, thank you for your question. As
we discussed, both when you were kind enough to visit us, as
well as with your staff--
Mr. Poliquin. No, not to visit you. I paid an unannounced
house call because you folks weren't responsive to our staff in
getting the data. So it wasn't a scheduled visit. I just showed
up.
Ms. Ramoni. We appreciate that.
Mr. Poliquin. Well, I appreciate getting--
Ms. Ramoni. And--
Mr. Poliquin [continued]. --us this data. How do we get
this data?
Ms. Ramoni. We explained to you at that point that that
data currently is not in the VA's hands, that we had made
efforts to--
Mr. Poliquin. So how do we get this data?
Ms. Ramoni. The NIH would have to cooperate with us in
releasing those data which would require a Congressional
request.
Mr. Poliquin. Okay. Good. And that data can be released
directly, I think, Mr. Bergman, can't it to this Committee?
Thank you very much. I yield back my time. I don't have any.
Mr. Dunn. Thank you Representative Poliquin. Representative
Kuster.
Ms. Kuster. Just a quick--
Mr. Dunn. You have five minutes.
Ms. Kuster [continued]. --question, if I could. This is for
Dr. Ramoni. We have been talking about bridging the gap
between basic research and clinical research, and my particular
interest is brain health diagnostics.
The Director of National Institute of Mental Health, in
2013, stated ``We must set our sights higher than a 19th
century approach for mental health diagnosis.'' So physicians
need more than the current symptom-based categories. Symptoms
alone rarely indicate the best choice of treatment. My question
to you is can the VA support bio-marker discovery and
validation, and pursue the deployment of at least two
additional brain health diagnostic measurements before 2023?
And if anyone else has any comment on that, I am happy to
hear.
Ms. Ramoni. Thank you for that question. As you heard,
several of my priorities touch on mental health, with PTSD,
suicide prevention, TBI, opioid use disorder, and it is a high
priority of ours to move from symptom-based diagnostics to bio-
marker based diagnostics. Even our work in Gulf War illness, we
are moving towards bio-marker based diagnostics.
To that end, we are developing road maps for a set of
projects that are intended to lead to objective bio-marker
diagnostics for both PTSD and TBI, and we are not doing this
alone. We are working in collaboration with NIH, with DoD, and
with co-inveterate bioscience and industry partners in order--
that this should move forward as quickly as possible.
Ms. Kuster. Great. Thank you very much, and I yield back.
Mr. Dunn. Thank you very much, Representative Kuster.
Representative Arrington--
Mr. Arrington. Thank you.
Mr. Dunn [continued]. --you are recognized for five
minutes.
Mr. Arrington. Thank you, Mr. Chairman. I, too, believe in
research and the investment we make as a Federal government to
discover, to solve problems, and I think that no place on
planet Earth do we do that better than in the United States of
America, and I think a part of that is the investment the
Federal government makes.
But we have got to do it in a smart way, in a strategic
way, in a cost-effective way. We have to know what our core
competencies are and what we are not as competent in, where
there is greater expertise in the marketplace. So I think my
colleague, Mr. Poliquin is--I appreciate his passion for making
sure this is working the way it is supposed to, and we have an
oversight roll, obviously in that.
And I guess my first question is, what is the process by
which we engage in the research agenda? When you set that
agenda, and there have been questions about how do we prevent
mission creep? How do we focus on our area of interest and
impact, which is those things that affect the unique community
of our veterans, as opposed to cancer and other areas of
research that are important, but they affect everybody? But we
are trying to get at those specific issues that plaque the
veteran community.
What is the process? Do you all bring that to the VA
Committee or some Subcommittee prior to the concrete drying on
that agenda so that we can provide some input and challenge you
on why you are focused on area X, Y, or Z?
Dr. Clancy?
Dr. Clancy. In terms of setting priorities for the research
overall, we have some broad frameworks, right, that this is
important to veteran's health. We are not going to fund it
unless it is a veteran focused project.
I think the trickiest part is the one that you and a couple
of your colleagues have keyed in on. The distinction between
conditions that we know to be unique to veterans and what they
are suffering right now, and conditions that are common, very
prevalent--
Mr. Arrington. Right.
Dr. Clancy [continued]. --among veterans but also among
other Americans as well. Creating that bright line is sometimes
harder than you might think. For example, when Mr. Poliquin was
asking about learning from VBA claims, which I think is a great
idea, there are some exposures that have a very long latency
and we might not know without having done research.
In general, we are looking to our advisory committee, to
researchers themselves, to lots and lots of stakeholders,
veterans service organizations, and so forth. To the best of
knowledge, we have not come to the Congress. We certainly give
you reports on the other side. We could certainly make that
part of a budget submission so that you would have a better
sense, I think.
I am not sure how close you want to get to that. Some
people might think that was politicizing things too much, as
opposed to substantive interest, which has been very much the
theme of today's conversation.
Mr. Arrington. I think it is part of our oversight role. I
mean, I don't--I think it is too late after we see the work
that you are doing to suggest that it is inside or outside the
purview of the mission for research at the VA.
But nevertheless, I think I am interested in how we can
improve that process, so we are better engaged on the front
end. How much--what percentage of the research at the VA is
translational versus fundamental? Is it 50/50, Dr. Ramoni?
Ms. Ramoni. So that is an area that I am, as you know,
keenly focused on. Currently, the majority of our research is
basic research, and some of that basic research, of course, is
in veteran focused areas. For instance, a non-opioid pain
medication is being researched in basic science, or traumatic
brain injury--
Mr. Arrington. Just in the interest of time--
Ms. Ramoni. Yes.
Mr. Arrington [continued]. --and I know I keep cutting you
off, and I do apologize, but--
Ms. Ramoni. But--
Mr. Arrington [continued]. --I think it is an opportunity.
Ms. Ramoni. Yes.
Mr. Arrington. If I were there with you, I would say what--
where can we have a strategic--
Ms. Ramoni. I agree.
Mr. Arrington [continued]. --advantage and focus given our
strengths, et cetera, sort of SWAT analysis. I would say--
Ms. Ramoni. Right.
Mr. Arrington [continued]. --we should be more
translational, less basic. NIH can do basic, all these other
institutes. Let's focus more on how we get at solving the
problem, and a quicker way, and I would also say, ``Can we use
the inside of the Veteran Hospital System, Health System?''
Ms. Ramoni. Yes.
Mr. Arrington. It is the largest in the country.
Ms. Ramoni. Okay.
Mr. Arrington. How do we tap into that, like you did with
tele-medicine. That is why you are leading in tele-medicine.
That is a leadership role for the VA. How to use the patient
material and all that you have, but with some flexibility that
you don't have on the outside, that my friend from Baylor
College of Medicine doesn't have because of restrictions, how
do you tap into that, so we can translate therapies and
devices, so we can save lives?
That is a question I have. I am out of time, but let's talk
about that. Let--you all come over to the office. I will come
see you, and let's see if we can't share some thoughts and
ideas on how to--
Ms. Ramoni. I would welcome that.
Mr. Arrington [continued]. --have a--
Dr. Clancy. Mr. Chairman, could I make one quick point? One
area where we do take great advantage of our system, and this
is just getting started but very, very exciting. You may be
aware that clinical trials are unbelievably expensive because
effectively every study creates a separate infrastructure which
is then disbanded.
Because of our integrated system and an electronic record,
we are actually now funding some point-of-care studies where
patients are randomized when they are being seen for care. We
are collecting data from the electronic record which takes the
cost of a clinical trial and reduces it by orders of magnitude.
So we are with you, and we would love some follow-up.
Mr. Arrington. Thank you for that. Mr. Chairman, I yield
back.
Mr. Bergman. [Presiding.] Thank you. I am going to yield
myself five minutes. That will complete the second round. I
think--Representatives Brownley and Kuster, you have no more
questions. Mr. Poliquin, you would like one more round?
Mr. Arrington, would you like any more time?
Mr. Arrington. I am going to reserve mine for a meeting--
Mr. Bergman. Okay.
Mr. Arrington [continued]. --but then, I appreciate their
comments.
Mr. Bergman. All right.
Dr. Clancy, just--if you could take for the record, I would
really like to know how many dual appointment researchers we
have across the spectrum. Okay? And if you can give me a
number, I assume you can give us a name. Okay?
So a by name, which then would therefore assume a by
location list, because I sense across the Committee that there
is keen interest in the how things are getting done, and not
that all of you don't have--you know all your data, you know,
because you do. But it is important for us to hear it from
boots on the ground as well. So I think that is going to be an
important step going forward.
Dr. Ramoni, Mr. Poliquin brought up problems with data
sharing between VHA and VBA. What are some of the impediments
to working with VBA?
Ms. Ramoni. Thank you for your question. So I think the
first impediment is simply an historical inertia. We simply
haven't worked that much with VBA in the past, although some of
our researcher now are beginning to use VBA data, for instance
in our suicide prevention work and also in our evidence-based
policy group.
What would need to happen is to have a data use agreement
with VBA, and to have that prioritized in both on the ORD side,
which it certainly would be, and also on the VBA side so that
we can establish those relationships and also have that work
properly staffed because sharing data takes curation. It takes
explanations of the data. It takes having some understanding
from the VBA side.
Mr. Bergman. Is there any ongoing institutional resistance
based on the, you know, old ``if not invented here'' syndrome
type of thing? I mean, is there--do we have any cultural
barriers that we need to break down between VHA and VBA?
Dr. Clancy. I don't think so.
Ms. Ramoni. I don't think there are cultural barriers.
Again, it has been a sort of inertia that we both need--we need
to work on both sides to break down, and I certainly am
committed to do so. And as we proceed, we will, of course, keep
this Subcommittee informed and should we encounter any of the
barriers you mentioned, we are grateful for your support.
Mr. Bergman. Oh, we know that human behavior is such that
everyone in a, if you will, in a chain of command or a food
chain, they look up to see the behavior above them. And if the
leadership at all levels is not having cross-talks, cooperating
across whatever boundaries might be there, the organization
will emulate those qualities of their leadership, and that is
why it is so important that--it is kind of like, I don't know
if you any of you are parents, but you know, kids watch their
parents. And if the parents are talking the kids pay attention.
If the kids think the parents aren't talking, they are going to
try to, you know, divide and conquer you.
But we are here together in this, and you know, not to
overblow the family analogy, but we are a family. We are a
family that is dedicated to the results for veterans, and that
is pure and simple the mission of the family.
Dr. Ramoni, in NAVREF's testimony, you asked that the VA
share the scope, criteria, and assessment for the Nonprofit
Program Office's out brief reviews. Could you please provide
those to the Committee as well? Second, are these out briefs
something the VA is willing to share with NAVREF? I mean,
again, in the spirit of sharing information?
Ms. Ramoni. Would the out briefs that--excuse me, sir. The
out briefs at each NPC?
Mr. Bergman. At the reviews, at the review level?
Ms. Ramoni. Yes. We would leave it to the discretion of the
local NPC to share those because not every NPC has a
relationship with NAVREF, but we have no desire to not make
those publically available. We would certainly make those
available to NAVREF if we were given the permission of the NPC.
Mr. Bergman. Okay. Well, it is, you know, again it is going
back to breaking down those barriers--
Ms. Ramoni. Right.
Mr. Bergman [continued]. --that inhibit the results and
giving--
Ms. Ramoni. Right.
Mr. Bergman [continued]. --us the, you know, the outcomes
that we all are striving for, and sometimes outcomes aren't--
isn't a strong enough work. It means results--
Ms. Ramoni. That is right.
Mr. Bergman [continued]. --related to the veteran. So with
that, I am going to yield back. Mr. Poliquin, you get the third
and final strike.
Ms. Ramoni. Thank you, sir.
Mr. Bergman. Round, I am sorry.
Mr. Poliquin. Thank you, Mr. Chairman, very much.
Appreciate if you set that clock to eight minutes, instead of
five, but in any event.
Dr. Clancy, who oversees the investigators? My--the reason
I ask that question is my understanding--correct me if I am
mistaken, is that the investigators or researchers--I am using
investigators because that is what--Dr. Ramoni taught me that
word.
If these individuals, I believe, are hired by the local VA
hospitals around the country, so they are employees of the VA,
and at the same time they might work for a terrific medical
institution like at Baylor, at Harvard, or at Case Western,
whatever it might be. And they then have authority to apply for
grants, get the grants, and then determine where the
administrative dollars goes, notwithstanding what
Dr. Klotman said earlier.
So who is overseeing those investigators to make sure
everything is going the way it should be?
Dr. Clancy. Well, as Dr. Klotman pointed out earlier, there
is a very careful time and attendance record. The VA-- actually
from the time of my earliest training with--
Mr. Poliquin. No, I am not really asking that,
Dr. Clancy. Thank you for that. What I am asking is, is
there anybody looking over the investigator's shoulders to say,
``You know, every time you apply for a grant, and I know you
work at XYU, University,'' that that grant money goes to XYU
because you are applying for that and you have to put it on the
grant, but the administration is also done by that university.
Is anybody serve as a check and balance to that individual?
Dr. Clancy. Well, to some--
Mr. Poliquin. Or are we doing it now?
Dr. Clancy [continued]. --extent, we would expect the NPCs
to do that. I am going to guess that a fair amount of that is
delegated to the discretion of the investigator--if I could
just finish for a moment.
Mr. Poliquin. Sure.
Dr. Clancy. If I am splitting my time five-eighths, three-
eighths, that would be a very common break because you have to
be five-eighths funded to get VA research funding. But if I can
say on my three-eighths time ``I am applying for a grant from
NIH,'' that would be okay the way we have been doing business.
Mr. Poliquin. No, what I am looking for is if you have an
investigator--and what Congressman Bergman asked is a really
good one. Who are these people, where are they located? If you
have 150--oh, I am just choosing a number. I think it is
probably pretty close. Is that if you have 100 of them that are
always doing the administrative work, where they work, not at
the VA but at their research affiliate, their academic
affiliation, that would be a concern of mine.
Dr. Clancy. I would agree.
Mr. Poliquin. Okay. Good. So there is no one that oversees
that except us, correct?
Dr. Clancy. I think you have brought a unique lens--
Mr. Poliquin. Okay.
Dr. Clancy [continued]. --and intensity to--
Mr. Poliquin. Okay.
Dr. Clancy [continued]. --our focus--
Mr. Poliquin. Here is why this--
Dr. Clancy [continued].--and we appreciate that.
Mr. Poliquin. --matters, Dr. Clancy, and everybody here. Is
that we have a situation where there is an inherent conflict of
interest, and we are looking at very big amounts of dollars. A
lot of bacon.
You have $1.2 billion, roughly, of grants that are provided
by NIH, and the DoD, and others, in one year. And if you say
``roughly,'' if we use our low-cost provider over here, the
NPCs, right, at roughly 25 percent, that is roughly $900
million of research, roughly, and about $300 million in one
year of administrative overhead and so forth and so on, to
administrate those--oversee those grants, make sure that they
get--research gets done.
Well, what if you are overpaying? What if it is not 25
percent, what if it is double that, like has been discussed
here? What if it is more than that? That is another $300
million a year. So you are getting less research and more
overhead. We see that everywhere. Everywhere, frankly, in the
non-profit sector. Not picking on anybody.
That is why I want to see the data. I want to see what
grants were issued, who did the research, how much money for
the research, how much money for the overhead, who these
investigators are, and what their record is of awarding that
administrative work?
And on top of that, you have the Inspector General's report
that says, ``This ain't going well,'' and that just came out.
So I am not trying to pick on anybody. We are all responsible
for taking care of our veterans. Thank you. We are not
clinicians, but it is our responsibility to make sure that the
dollars are going to the right place, and we are not
overpaying. It is that simple. Yes?
Ms. Rusconi. I would like to make a point of clarification
which is I understand what Dr. Clancy is talking about, that
the NPC might have an input into where someone, a PI, would
submit the grant, but the reality is that throughout the
country, there are lots of times that the NPC isn't even aware
that that grant is being submitted. So there is absolutely no
way that the NPC could be part of it.
Mr. Poliquin. But 30 years ago, you folks were created by
Congress specifically to solve this problem, correct?
Ms. Rusconi. Correct.
Mr. Poliquin. Well, I would like to know how much of the
business you are getting, because you are the low-cost
provider.
Ms. Rusconi. We would also like to know.
Mr. Poliquin. Good. Pretty simple, Jack. Excuse me, Mr.
Chairman. I yield back my time.
Mr. Bergman. Am I now Chairman Jack? Is that what it is? I
am no longer General Jack?
Mr. Poliquin. It is whatever you would like, sir, as long
as the--
Ms. Kuster. I vote general.
Mr. Poliquin [continued]. --this summer.
Ms. Kuster. Just for the record.
Mr. Bergman. Yeah, so. All right. Well, thank you to all
the Committee Members for the--this has probably been one of
the more focused and direct Subcommittee meetings and hearings
that we have had. So I appreciate everybody's input, especially
all of you at the testimony table, because together we do make
a difference and we make a positive different. And if it was
all easy, it would all have been done long time ago and we
would all be doing other things.
So I really appreciate your continued intellectual
engagement here for our penchant for details now that big data
allows us to get those details in a relatively expeditious and
accurate manner. So our thanks to all the witnesses today. You
are now excused. Ranking Member Kuster, would you like to make
any comments before we close?
Ms. Kuster. I have a brief closing statement, and one point
I would like to leave the record open long enough for the VA to
respond to the questions that have been asked today.
The perspectives we heard today are important points of
view to consider as we ultimately have a dramatic impact on the
quality of care to our veterans in New Hampshire and all across
the country, and to community providers, and indeed, civilians
across this country. While I appreciate the hard work and
dedication of the witnesses and organizations that you
represent, the testimony today does concern me. I appreciate
the great work that the VA Non-Profit Research and Education
Corporations, or NPCs, conduct to oversee crucial VA research
with frugality. However, it is concerning that the availability
of NPCs at all VA medical centers may be limited.
Likewise, I appreciate the robust academic affiliations the
VA currently enjoys, and as I mentioned in my comments,
Dartmouth College and Dartmouth Medical School has proven to be
a wonderful partner in expanding and improving veterans' health
care in rural New Hampshire. However, it concerns me that some
academic institutions may charge more than necessary to
administer Federal research grants, and insuring the most
efficient system is crucial to maximizing resources this
Congress provides to care for our veterans. And I think you
have heard this as a bipartisan concern.
I recognize the VA has been unable to provide clear
guidance in an expeditious manner as to how this research money
is to be distributed, and I encourage the VA to vitalize this
guidance as quickly as possible, and share that with this
Committee. I believe there is a great opportunity here for all
stakeholders to work together and insure that VA's research
regime is efficient and effective.
To that end, I ask my colleagues to consider joining me in
convening a roundtable of relevant stakeholders to further
discuss these issues, and as I mentioned specifically, I would
love to include the bipartisan Heroine Task Force, and both
Committees to engage in this discussion.
Our experience with the opioid epidemic has made effective
medical research, especially into pain management and substance
use disorder, an acute concern of members across this country.
We know the importance of getting new research on pain,
addiction, and mental health is important. Veterans are
uniquely impacted by the opioid epidemic because over 50
percent of veterans experience chronic pain. Our veterans need
the latest in medical research to combat this problem, and I
hope to advance legislation soon that would centralize and
improve pain management at the VA by creating centers of
excellence.
Of course, this is hardly the only area in need of
additional research. I know veterans with upper body prosthetic
needs experience a limited suite of options. Creation of a
center of excellence on bionics or upper prosthetics is needed
to further meet the needs of veterans. There is emerging
research and technology, and as I appreciate your mention in
your opening remarks, about the Luke arm, but assuring that the
VA is adequately able to deploy the latest technology is
crucial to improving our veterans' quality of life.
So this serves to underscore my commitment to delivering
the highest quality of care to our veterans by ensuring that
the VA remains a leader in medical research. I thank you for
your time, and I yield back.
Mr. Bergman. Thank you, Ranking Member Kuster. It has been
nearly one year after our research hearing last June, and it
quite frankly, does not appear that the VA has made any
improvements on its utilization of the NPCs. Budgets are still
tight, yet we continue to find examples of VA not utilizing the
available options for additional funds.
As we have heard, NPCs have contributed over two billion,
that would be with a ``B,'' to VA research over the past decade
and could contribute more if they were to administer the grants
for research projects conducted within VA. VA should not be
paying overhead costs without getting the benefit of
reimbursement.
It is also critical that the research office have access to
VBA's data so that it may better meet its mission of veteran
centric research. This data would be extremely beneficial in
determining what diseases and disorders to examine and help
guide ongoing projects.
I hope that our discussion will open the door to better
communications because quite frankly, I am pretty tired, and I
think we all are, of hearing about missed opportunities within
VA due to one office not communicating with another. VA's
research budget exceeds $1 billion annually. So one would think
that the accomplishments it has contributed to veterans and the
American public would be many, but what we have heard here
today is that that is not the case.
Certainly, VA can tout some major accomplishments over the
past several years, but unfortunately, they are not necessarily
in areas significant to veterans or related to their service.
Moreover, many of these results are being implemented at only
one medical center or one VISN which limits the benefits
received by veterans across the country.
Simply put, VA research needs to be more focused on
specific conditions prevalent among our Nation's veterans, and
the department must follow through on projects so that there
are actual clinical benefits to show for all of the funding the
research program receives. So bang for the buck. It is past
time to witness the urgency this long-standing problem
deserves.
I ask unanimous consent that all Members have five
legislative days to revise and extend their remarks, and
include extraneous material. Without objection, so order.
I would once again like to thank all of our witnesses and
audience members for joining in today's conversation. With
that, this hearing is adjourned.
[Whereupon, at 11:51 a.m., the Subcommittees were
adjourned.]
Statements For The Record
Submitted by the Coalition to Heal Invisible Wounds
Roger Murry, Executive Director
Chairman Wenstrup, Chairman Bergman, Ranking Member Brownley,
Ranking Member Kuster, and Members of the Subcommittees:
On behalf of the Coalition to Heal Invisible Wounds, thank you for
this opportunity to provide written testimony regarding the VA's
research partnerships, priorities and the extent to which the VA
effectively translates research findings to the clinical setting to the
benefit of Veteran patients. We commend the Subcommittees' leadership
in addressing these critical issues.
The Coalition to Heal Invisible Wounds was founded in February 2017
to advance policy reforms that widen and expedite the pipeline for new
therapies and diagnostics for post-traumatic stress disorder (PTSD) and
traumatic brain injury (TBI). Coalition members innovate at all stages
of the therapy development life-cycle and also serve Veterans who most
urgently require mental health interventions. \1\
---------------------------------------------------------------------------
\1\ The Coalition's members are Cohen Veterans Bioscience (co-
chair), the Military Veterans Project, NAMI Montana, Otsuka America
Pharmaceutical Inc. (co-chair), and Tonix Pharmaceuticals.
---------------------------------------------------------------------------
According to the VA PTSD Psychopharmacology Working Group: ``The
urgent need to find effective pharmacologic treatments for PTSD should
be considered a national mental health priority.'' \2\ Despite the
``high prevalence and costly impact'' of PTSD in military personnel and
Veterans, ``most patients are treated with medications or combinations
for which there is little empirical guidance regarding benefits and
risks,'' and there is ``no visible horizon for advancements in
medications that treat symptoms or enhance outcomes in persons with a
diagnosis of PTSD.'' The scenario is similar for TBI and these two
conditions often coexist but may also occur independently in the VA
population.
---------------------------------------------------------------------------
\2\ John H. Krystal et al., It Is Time to Address the Crisis in the
Pharmacotherapy of Posttraumatic Stress Disorder: A Consensus Statement
of the PTSD Psychopharmacology Working Group, J. Biological Psychiatry
(2017) http://www.biologicalpsychiatryjournal.com/article/S0006-
3223(17)31362-8/abstract
---------------------------------------------------------------------------
The Coalition believes that better diagnostics and therapies will
spur more Veterans to seek care. According to a 2017 survey of over
4,000 Iraq and Afghanistan Veterans of America (IAVA) members, 46
percent report having PTSD, while 19 percent report having TBI. \3\
Only 16 percent of IAVA members believe troops and Veterans are getting
the care they need for mental health injuries and stigma remains the
top reason Service members and Veterans are not seeking care. A major
reason why IAVA members stop seeking care is that they do not think
that the treatment will work.
---------------------------------------------------------------------------
\3\ 2017 Member Survey; Iraq and Afghanistan Veterans of America.''
Accessed May 9, 2018. https://cultureondemand.github.io/iava-report/
---------------------------------------------------------------------------
An implicit promise of world-class health care is a strong research
function. Veterans have earned the right to world-class health care.
Better research will lead to better care of our Veterans who suffer
from PTSD, TBI, and other mental health conditions that are prevalent
among the veteran population. We strongly believe that the VA can
become a leading partner in delivering new therapies and diagnostics;
it has many outstanding assets and institutional strengths, as well as
the desire to overcome the institutional hurdles to establishing
advanced research partnerships.
The Coalition seeks to advance discrete reforms at the VA to
support cutting-edge research partnerships. We focus on enhancing big-
data research partnerships, standardizing approval and oversight of
multi-site clinical trials to accelerate the development of new
therapies, and spurring the development of new brain health diagnostics
for clinical use. Ultimately, the VA can align its management of
clinical trials much closer to best practices, which will lead to
increased clinical trial success rates and the accelerated development
of new diagnostics and therapies for conditions that disproportionately
impact Veterans. We believe that in 2018, with appropriate oversight
from Congress, the VA can pursue several targeted reforms that would
serve as significant first steps in this process:
1.Permit sponsors to use commercial IRBs accredited by the
Association for the Accreditation of Human Research Protection Programs
(AAHRPP);
2.Clarify that the Central Office has the authority to determine
all information security requirements for a multi-site trial, direct
the VA to develop a central list of compliant vendors and direct the VA
to staff the office appropriately;
3.Direct the VA to study the obstacles sponsors face in recruitment
and develop a plan to support Veteran participation in clinical trials;
4.Develop a master plan to support clinical research; and,
5.Direct the VA to work with pertinent Federal and non-governmental
partners to deploy at least two additional brain health diagnostic
measurements for clinical use at VA facilities before 2023.
We are grateful for the opportunity in this testimony to describe
in more detail both these initial steps and the overall trajectory for
reform.
A. Conduct and Support for VA's Research Partnerships
We support the work of the Subcommittees and the VA to bridge the
gap between basic research and clinical research. This work complements
ongoing examinations within the Office of Research and Development, at
NAVREF and their member Nonprofit Research and Education Corporations
(NPC), and within the private-sector research community as to how the
VA can help get more research into the clinic. Major stakeholders share
an understanding that the current diagnostic and therapeutic options
available to Veterans are not sufficient, and that creating a more
predictable and streamlined research approval and oversight process at
the VA will attract more investment to address conditions that are
specific to or prevalent among the Veteran population. Enhancing
research pathways also will help the VA deliver better care to
Veterans.
An important place to begin bridging the gap is to standardize
clinical trial reviews. While some VA clinics have been able to
participate in multi-site clinical trials, sponsors report a widespread
lack of standardization in the approval and oversight of sponsored
clinical research at the VA. This delays VA trial site start dates,
increases research costs, and discourages research sponsors from
partnering with the VA. We encourage the Subcommittees to
comprehensively review how the VA can streamline the approval process,
identify and propagate best practices, and develop true continuity in
the approval and administration of clinical trials. For 2018, three
reforms, described below, are close at hand and would immediately draw
more clinical research to the VA.
1. Institutional Review Boards (IRBs)
IRB reviews ensure that clinical trials abide by clear ethical
guidelines and protect the well-being of research participants, but
sponsors need the reviews to be prompt and consistent. Despite earnest
efforts by many within the VA to standardize and improve the IRB
process (namely, by standing up a central IRB), the IRB process
continues to be a source of major delays for sponsors. In fact, despite
a decade or more of work on the central IRB, some multi-site clinical
research sponsors, due to frustrations with the central IRB, have
reverted to using local IRBs. In light of the high-quality, private-
sector options available, we do not advise further efforts to enhance
the current IRB process as it relates to sponsored research. Instead,
we recommend that the Subcommittees move to permit sponsors to use
commercial IRBs accredited by the AAHRPP. Stakeholders within the NPC,
industry and non-profit communities broadly support this proposal.
Allowing the use of accredited commercial IRBs would allow for
predictable and frequent IRB review processes and timelines. In
pursuing this reform, it is important to consider and account for,
where relevant, how this step would impact the role of other review
committees, VA requirements for education and training, VA-specific
regulatory requirements related to human subjects research, and the
workload for the local and NPC IRBs. We believe that each of these
considerations can be adequately addressed.
2. Information Security Officer (ISO) Reviews
ISO reviews seek to ensure the safety of patient data. The reviews
are often lengthy and unpredictable, leading to security requirements
for the same study that can differ by VA clinic. Local ISOs are
extremely busy and have variable knowledge of clinical research data
storage and transfer requirements. Guidelines for ISOs can be unclear
and outdated, while many ISOs feel organizational pressure to pursue
the most conservative approach, and constrain the VA from participating
in cutting-edge research. Further, there is no central list of
compliant research vendors, so vendors are vetted and re-vetted by
local ISOs.
A centralized information security review for multi-site clinical
research would allow for a more thorough, standardized, and appropriate
review process, while reducing delays that often occur at the local
level. The VA has begun to move in this direction. The Central Office
recently set up an office to assist local ISOs with reviews of multi-
site research. However, the Central Office does not have clear
authority to manage all information security requirements for a multi-
site trial. Congress should clarify that the Central Office has the
authority to determine all information security requirements for a
multi-site trial, that it should develop a central list of compliant
vendors and direct the VA to staff the office appropriately. These
steps would standardize the scope and timing of the ISO review process,
as well as send positive signals to potential research sponsors.
3. Clinical Trial Recruitment
Veterans should have the right to be fully informed of all of their
treatment options, including the potential benefits and risks of
clinical trial participation. This allows Veterans the opportunity to
benefit personally from cutting-edge research opportunities and assist
the wider community as a whole through trial participation. In fact, in
oncology and increasingly other areas of medicine, clinical trials are
now the standard of care. Research sponsors report widely varying
experiences recruiting research participants. Some VA sites, for
example, maintain a database of VA patients that have indicated their
desire to be contacted about new opportunities to participate in a
study and allow sponsors to effectively recruit. Other VA sites do not
offer this or other institutional supports for recruitment, leading to
extended recruitment timelines and increased cost of the research. Some
sponsors have been unable to fill the patient population needed for the
trial, compromising the ability to understand the efficacy of the
treatment being tested.
Recruitment problems are not unique to the VA. According to
researchers at Vanderbilt and Duke Universities, nearly 1 in 5 clinical
trials are either terminated for failed participant accrual, or are
completed with less than 85 percent of the expected enrollment.
Recruitment challenges increase the cost and reduce the speed with
which advances in medicine reach Veterans and the general population.
VA research stakeholders have expressed an array of difficulties
related to recruitment, but it is not yet clear what specific reforms
the VA could undertake to best facilitate enrollment. We would advise
that Congress direct the VA to study the obstacles sponsors face in
recruitment and to develop a plan to support Veteran participation in
clinical trials.
B. Translating Research Findings to the Clinical Setting to the
Benefit of Veteran Patients.
1. Master Plan to Support Clinical Research
While improving clinical trial management will spur more private
sector activity, the VA should also play a direct role in bridging the
gap between basic research and clinical research. Today, grant money is
divided across too many different projects, leaving each with too
little money to appropriately design and run a clinical trial, and
unable to lead to the next step of investigation. The VA should assess
how federal agencies and the private sector are supporting clinical
research into new diagnostics and therapies for conditions that
disproportionately impact Veterans. The VA should then develop a master
plan that provides for strategic support of clinical research,
including for private sector activity, to speed developments that
address those conditions. The plan should include innovation grants for
external research, such as the Industry Innovation Competition, in
which the VA spurs activity in the private sector to help solve VA's
most pressing challenges. The plan should complement the comprehensive
plan for biomarker discovery and validation described blow.
2. Diagnostics Research Mandate
As our members engage every day with Veterans suffering from PTSD
and TBI, they see an urgent need for mechanism-based diagnostic tools
to precisely diagnose those conditions. Using symptom-based diagnostic
tools alone diminishes the ability of physicians to effectively
diagnose these multi-faceted disorders as well as overcome the known
challenges of diagnosis such as stigma and delays in qualified clinical
assessment. In 2013, while still serving as Director of the National
Institute of Mental Health, Dr. Tom Insel stated that ``the diagnostic
system has to be based on the emerging research data, not on the
current symptom-based categories,'' and that ``we must set our sights
higher'' than a 19th century approach. \4\ ``Indeed, symptom-based
diagnosis, once common in other areas of medicine, has been largely
replaced in the past half century as we have understood that symptoms
alone rarely indicate the best choice of treatment.'' Clinicians need
new tools to more precisely diagnose those suffering from PTSD and TBI,
which requires the VA to effectively translate research findings to the
clinical setting for the benefit of Veteran patients.
---------------------------------------------------------------------------
\4\ ``Post by Former NIMH Director Thomas Insel: Transforming
Diagnosis.'' NIMB Director's blog. Posted April 29, 2013. Accessed May
9, 2018. https://www.nimh.nih.gov/about/directors/thomas-insel/blog/
2013/transforming-diagnosis.shtml
---------------------------------------------------------------------------
Diagnostics are objective, measurable predictive factors that help
doctors improve care. For example, the FDA recently approved a blood
test to improve the diagnosis of concussions, which could eliminate the
use of unneeded CT scans in at least a third of those with suspected
brain injuries. Writing in the VA's PTSD Research Quarterly, VA
researchers determined that ``we appear to have reached a watershed in
the development of biologically-based interventions for the prevention
and treatment of PTSD.'' \5\ Further, understanding the multiple and
interacting mechanisms of malfunction in each stress system will be
critical to advance the diagnosis and treatment of trauma-related
mental health disorders into the precision medicine era.
---------------------------------------------------------------------------
\5\ ``Biomarkers for Treatment and Diagnosis.'' PTSD Research
Quarterly. Accessed May 9, 2018. https://www.ptsd.va.gov/professional/
newsletters/research-quarterly/V26N1.pdf
---------------------------------------------------------------------------
According to a recent literature search of PTSD biomarker discovery
studies, researchers identified over 800 PTSD biomarker candidates, but
none have been validated or approved by the FDA for clinical use. There
are many reasons for the failure to validate PTSD candidate biomarkers
to date, but most can be overcome by bringing together large data sets
and standardization of research techniques. For example, targeted
research based on big data analysis is more likely to direct
researchers toward plausible candidates that can be replicated and
validated. Given the state of the science, we believe this is not only
possible but also probable by 2023.
To bridge the gap between basic research and the needs of Veterans
and their doctors, Congress should require the VA to work with
pertinent Federal and non-governmental partners to build a
comprehensive plan for biomarker discovery and validation including the
deployment of at least two additional brain health diagnostic
measurements before 2023 for clinical use at VA facilities, and funding
a broader long-term biomarker study through the Department of Defense
(DOD). The statutory objective would help VA leadership marshal
sufficient resources and implement administrative reforms to boost
public-private partnerships and power the discovery of biomarkers.
C. Conclusion
The Coalition to Heal Invisible Wounds thanks the Subcommittees for
its work to strengthen VA medical and prosthetic research program. We
strongly believe that the VA has the potential to be a world-class
research partner to the private sector, enabling better health care for
Service members and Veterans, and the initiatives proposed above would
provide significant initial progress toward that goal.
. We encourage the Subcommittees to continue to engage with
stakeholders to develop a multi-year plan that provides for continual
improvements to data-sharing, clinical trials and therapy and
diagnostics research. Comprehensive reforms would address the many
other pacing limiters of clinical research, such as limitations on
protected time for physician-researchers participating in sponsored
research, and budget and Cooperative Research and Development Agreement
(CRADA) negotiations. Comprehensive reform would also advance the best
practices that have helped clinical trials succeed at the VA, such as
the lead site model pioneered by several innovative NPCs.
Rick Weidman
Executive Director for Policy & Government Affairs
Regarding
Department of Veterans Affairs Medical and Prosthetic Research
Program
Good morning, Dr. Wenstrup and General Bergman, and other
distinguished members of these two very important Subcommittees.
Vietnam Veterans of America (VVA) is pleased to have the opportunity to
present for your consideration our Statement for the Record on the VA's
medical and prosthetic research program. Also, for the record, we want
you to know how much we appreciate the work you do for our nation's
veterans.
As we all know, VA research is different from research sponsored by
other federal research agencies. According to the VA it is focused
entirely on veterans' needs. It is intramural, and more than 60 percent
of VA researchers are also clinicians who provide direct patient care.
In your letter to VVA you requested that we address three issues
related to VA research, which we do in this statement. However, we
would like to emphasize that our biggest issue with the Department's
research program is that it does not fulfill, in our minds, the purpose
for which it was established. And that is to conduct research that is
focused entirely on veterans' needs. We would, therefore, request that
you do a few things:
Request a Government Accountability Report (GAO) that
takes a comprehensive look at the VA research program, including
projects funded, the amount of funding expended, the source of the
funding and bench-to-bedside focused treatments and the reality of that
goal in as much as it is accomplished by the VA.
We ask that this be a report that takes a retrospective
look over the last 5 to 15 years of the program.
Issue 1: Department of Veterans Affairs partnership with nonprofit
research and education corporations, academic affiliates, and other
entities regarding administration of research funding as well as to
conduct and support research efforts.
The VA's total actual budgetary resources for Research &
Development for Fiscal Year 2017 was $1.8 billion, of which $673
million was direct appropriations. VA's research program also relies on
other sources of funding, non-federal as well as federal. For FY'17, in
addition to the direct appropriations, the department received $535
million for Medical Care Support, $425 million from other federal
agencies, and $170 million in non-federal funding. Though this pales
when measured against federal research dollars for the National
Institutes of Health, the Congressionally Directed Medical Research
Programs of the Department of Defense, and the Centers for Disease
Control and Prevention, it is certainly not insignificant.
VA proudly, and rightfully, points to some of the major
accomplishments coming out of its research program, e.g., the heart
pacemaker, the nicotine patch, the first successful liver transplant,
improvements in wheelchair design. However, we must question: How much
of what VA research has produced recently is of significant benefit to
veterans?
Conceptually, VVA has no argument with enlisting outside
researchers from not-for-profit research and educational corporations
and academic affiliates. For several years now, we have proposed the
creation of an external entity, headed by a qualified individual who
would be confirmed by the Senate, which would engage independent
scientists and medical researchers to conduct research on specific
health conditions of immediate consequence to veterans, conditions
stemming from battlefield trauma, e.g., the ingestion of toxic
substances from burn pits in Afghanistan and Iraq, and other military
exposures such as oil well fire, sulfur fire, sand, dust, and
particulate matter.
We say this because for several years after the advent of the 21st
century, it is our understanding that little or no research was
conducted, for instance, on the long-term effects of exposure to Agent
Orange and other toxins that were so liberally sprayed in South
Vietnam. When the former head of the VA's Office of Research and
Development was asked pointblank a few years ago if and when Agent
Orange research would be funded, he replied with empty rhetoric and
could not cite any specific research program then underway or being
planned for the immediate future.
We would urge you to investigate how much money was expended on
just what specific, peer-reviewed research was conducted that has been
of salient benefit to our wounded warriors.
Finally, in brief response to the essence of the first question,
VVA has no qualms about expanding and enhancing the universe of
researchers who would respond to a Request for Proposal (RFP) for
specific areas of research, as long as there is strict oversight by the
appropriate staff at the VA and by you in Congress.
Issue 2: The extent to which VA's research projects and priorities
display a concentrated focus on issues and conditions that are specific
to or prevalent among the veterans population.
Much of our answer to this question is alluded to above. Basically,
we have not seen any concentrated focus in this regard. Why? Because we
believe VA researchers have been funded for the most part to conduct
research in their individual areas of interest which are not always of
relevance to specific health conditions unique to veterans exposed to
the inherent dangers in a combat zone.
Issue 3: The extent to which VA effectively translates research
findings to clinical settings to the benefit of veteran patients.
Again, the nugget of our comment here is in our responses to Issues
1 and 2. This is not to say that all research projects funded by the VA
are of little consequence to veterans. Important research has been
conducted in improving prosthetic arms and legs, for instance. But this
is the exception, not the rule.
We thank you for the opportunity to submit for your consideration
our Statement for the Record. Should you have any questions, we would
of course be pleased to reply.
Whistleblowers of America
Jacqueline Garrick, LCSW-C
Dear Chairman Roe and Ranking Member Walz;
Whistleblowers of America (WoA) is submitting this statement
because we are concerned about priorities for further research and the
proper management of research funds at the Department of Veterans
Affairs (VA). We are grateful for this opportunity to share VA insider
information with you and the rest of the Committee.
Sentinel Events:
Sentinel events usually involve wrongful deaths, surgery on wrong
patients or body part, loss of function, other surgical errors/
retention of foreign body, treatment delays or complications,
medication mismanagement, falls/injuries, suicides or overdoses of a
patient in or at a facility, assaults and other crime. According to a
study conducted by Johns Hopkins University in 2016 \1\, medical errors
would actually be the third leading cause of death in the United States
accounting for 220,000 to 440,000 annual deaths if the Centers for
Disease Control and Prevention tracked those deaths using the same
coding as the study.
---------------------------------------------------------------------------
\1\ Johns Hopkins Medicine, May 3, 2016 release
---------------------------------------------------------------------------
VA does capture some data on sentinel events (also known as adverse
events or medical errors) through its National Center for Patient
Safety. However, VA insiders note that these events are supposed to
undergo a root cause analysis (RCA) and other administrative reviews
but are inconsistently conducted and can be more punitive in nature
than corrective. Furthermore, these RCAs rarely generate adequate
process improvement recommendations that can be monitored, shared and
re-evaluated.
Congress should require VA to replicate the study
conducted by Johns Hopkins University and mandate that it provide an
annual roll up report of its sentinel events and related research on
the tools its uses to identify, manage, disclose, respond, remediate
and re-evaluate these adversities that risk patient safety.
Opioids and Pain Management Research Translation:
WoA has provided previous testimony on the problems it sees with
opioid use and pain management for veterans seeking care at VA. Our
belief is that care should be holistic and utilize multiple tools and
interventions. It should be driven by medical decisions not
administrative policies. Those medical decisions should be evidence
based and informed, which requires VA to engage in veteran-centric
research and translational activities to bring research into the
patient care environment. However translational research is often
lacking, and policies made by non-clinical managers drive outcomes. VA
research and development funding must give veterans, Service members
and their families priority. These research dollars must be aligned to
population data-driven needs.
WoA understands that pain cannot be managed to zero. However, pain
as the 5th Vital Sign can be confusing to patients and needs research
on alternative interventions to opioids to bridge gaps in prescribing
practices. For example, Chronic Pain Syndrome can be managed with
improved sleep hygiene, dietary changes, exercise (physical therapy,
yoga, stretching), chiropractic therapy, orthotic intervention usage,
as well as good calcium and Vitamin D levels. Strong occupational and
physical therapy programs as well as dieticians are indicated in
thorough pain management. However, these are all underfunded and under
studied areas of intervention. The Department of Defense (DoD) has done
some studies with Service members who have benefited from massage,
Reiki, yoga, acupuncture, aqua therapy and the adaptive sports
programs. In the private sector, pain management is an integral part of
the care management team. This has not been the case with VA and
military transitioning patients see the disparity in their treatment.
VA needs to give more attention to these techniques to close the parity
gap in pain management care.
WoA has met with the Veterans Cannabis Coalition because of our
shared concerns in addressing the opioid epidemic in America and
prescription drug use among VA patients. Regarding cannabis research
studies, the National Academies of Sciences (NAS) found, in a 2017
review of 10,000 existing cannabis studies, conclusive or substantial
evidence that cannabis is effective for the treatment of pain in adults
and limited evidence that it can improve the symptoms of posttraumatic
stress disorder (PTSD). The NAS report recommendations focus on the
broad need for improvements to research processes and high-quality
clinical trials. The VA is uniquely positioned to fully investigate the
effects and potential applications of cannabis. The health care needs
of veterans, particularly for alternatives to opioids for chronic pain
management, should make cannabis research a top priority within the VA,
and Congress should work to remove the existing barriers to research
and stigma imposed by the National Institute for Drug Abuse (NIDA). As
one physician noted to WoA, ``over the years, my practice has changed,
based on the changes in the medical literature. Cannabis research could
someday potentially change what the current medical literature states
is standard of care regarding pain management.''
As WoA has previously testified, the Federal Government has no
Center Of Pain Management Excellence (COPE) but could greatly benefit
from such a focus. Strategically located COPEs in partnership with DoD
were recommended by a joint task force report issued by the Army
Surgeon General in 2010 \2\. If this recommendation were instituted, VA
and DoD could be leading the nation in responding to the opioid
epidemic as required by President Trump. However, eight years later, we
still do not have these Centers, proper toxicology or accountability
for opioids, or standardized protocols for pain management that could
come from the proper research. Congress should ask for an update on
these recommendations, especially regarding the COPE.
---------------------------------------------------------------------------
\2\ The Pain Management Task Force Report: Providing a Standardized
DoD and VHA Vision and Approach to Pain Management to Optimize the Care
for Warriors and their Families made 109 recommendations. The report
was required by NDAA 2010.
Congress should authorize VA to partner with DoD and
other entities to establish a COPE.
COPE should lead efforts to create, delegate, and
integrate further studies on alternative to opioids for pain
management, including cannabis.
COPE should develop and institute plans and strategies to
translate research into practice.
Mental Health, TBI, and Suicide Prevention:
Mental health is the bailiwick of VA, especially related to (PTSD).
The VA had led the nation in researching PTSD and its treatment. It
houses a body of knowledge through the National Center for PTSD that is
unexceed anywhere else. However, as reported by the AFGE, there is a
high turnover rate among VA providers, so there is a constant need for
new clinicians to be supported and trained with innovative approaches
and techniques, such as with Virtual Environments (VE). For example,
these VE can help train providers to deal with difficult subjects to
discuss, such as Military Sexual Trauma (MST) or sexual dysfunction, or
suicidal ideation. Social Work students are already being trained in
these environments as well as military personnel in leadership courses.
These tools need further research and development for application in a
VA environment, but could expand training capabilities and reduce long-
term production costs.
Although VA collaborates with DoD on issues related to Traumatic
Brain Injury (TBI) there are still gaps in its ability to understand
and treat this range of brain damage, especially when there are co-
morbid conditions present. For example, in accordance with the VA/DoD
Treatment Practice Guidelines, ``For patients with PTSD, we recommend
individual, manualized trauma focused psychotherapies that have a
primary component of exposure and/or cognitive restructuring to include
Prolonged Exposure (PE), Cognitive Processing Therapy (CPT), Eye
Movement Desensitization and Reprocessing (EMDR), specific cognitive
behavioral therapies for PTSD, Brief Eclectic Psychotherapy (BEP),
Narrative Exposure Therapy (NET), and written narrative exposure.''
These are excellent standards of care but can be ineffective with
patients who are cognitively impaired, such as those with TBI or
Dementia. Thus, the above can leave veterans labeled ``treatment
resistant'' as opposed to misdiagnosed. While VA spends on average $30
million a year on brain research, DoD spends closer to $80 million.
Each agency has different populations it needs to study, so researchers
trying to deal with aging veterans find shortfalls in their
capabilities, especially on brain studies involving women veterans,
which is why Pink Concussion is seeking women veterans to donate their
brains. In a 2018 OIG report, (15-01580-108) it found problems with
providers who could not effectively diagnose TBI or differentiate it
from PTSD, which negatively impacted veterans' ability to obtain proper
service connection disability compensation and access medical care.
Investments should be made in exploring and testing some of the
innovative neurotechnologies that are available for identifying brain
functioning and treating or mitigating TBI impacts. Tools coming to the
market include brain performance trackers and wearables,
neuromonitoring, brain-computer interfaces, neuro-biofeedback, and
other cognitive aids that could also be explored for use in veteran
populations.
Research has also already correlated PTSD and TBI to increased
risks for dementia. Dementia onset also can stimulate new symptoms or
exacerbate existing mental disorders as cognitive capabilities
degenerate. As the veteran population with these conditions continue to
age, new protocols are needed to support a healthy aging process that
enhances the independence and integrity of the veteran while developing
and testing tools that can better assist caregivers to allow veterans
to age in place.
In 2013, VA, DoD and the Departments of Education and Health and
Human Services issued a National Research Action Plan (NRAP) for Mental
Health. Major commitments were made by all of the agencies and entities
involved for enhanced research coordination and governance,
prioritization, innovation and translational capabilities. However,
over the last five years, there seems to be little reporting on the
outcomes generated by the NRAP and its partners.
In July 2017, VA released data on veterans who have died by
suicide. Although compelling, the problem with the data release was
that it is not tied to any VA program outcome data or funding execution
information. There is no indication that VA uses this report in any
meaningful way to target its interventions or other approaches. In
fact, there have been several OIG investigations that recommend that VA
do more targeted outreach at the local levels. However, VA continues to
fund national awareness campaigns that have no evidence of
effectiveness. There is growing research that awareness campaigns do
not work or could even have an adverse impact because they normalize
the behavior they are trying to mitigate. \3\ Yet, in the last few
years, VA has awarded almost $100 million in contracts for ``Make the
Connection'' and the ``Veterans Crisis Line'' campaigns instead of
using those funds to address shortfalls at the call center, hire more
mental health providers, expand peer support or conduct local outreach.
Whistleblowers have noted that money gets spent on things like videos,
posters, dashboards or SharePoint sites that could have been allocated
for direct patient care, provider training or research.
---------------------------------------------------------------------------
\3\ University of Michigan, School of Public Health
---------------------------------------------------------------------------
Congress passed the Joshua Omvig, Clay Hunt, and the Chris
Kirkpatrick Acts in attempts to mandate VA suicide prevention efforts.
We lost Omvig, Hunt, and 20 other veterans a day, along with Dr.
Kirkpatrick to suicide while VA has struggled to provide evidence-based
interventions and support. Ongoing OIG and GAO investigations should
prove fruitful in identifying suicide prevention improprieties and
shortfalls along with recommendations for better practices.
The Committee should hold a hearing to learn more about
these mental health and brain treatment technologies to help prioritize
their research value.
Congress should require VA to lead an effort with its
sister agencies to update the NRAP goals and objectives and document
pertinent outcomes for veterans.
Congress needs to hold VA accountable for how it uses the
suicide population data it collects to inform the programs it creates
and how it aligns appropriated funds for these purposes. The Committee
should hold a hearing on suicide prevention funding to review OIG and
GAO findings related to waste, fraud and abuse.
Research Treatment for Tinnitus:
Tinnitus and hearing loss are the primary service connected
conditions adjudicated by the Veterans Benefits Administration. There
are double the number of veterans who are service connected for
tinnitus than there are for PTSD, yet the research funding for
audiology is minimal.
Tinnitus, which is a constant ringing or buzzing in their ears,
impacts so many aspects of a veterans' quality of life. It is often a
side effect within the ear or brain from other conditions,
environmental exposures (noise in a combat zone), or injury (TBI).
Depression, anxiety, lack of sleep and difficulty focusing or
concentrating are associated with tinnitus. Furthermore, tinnitus can
exacerbate PTSD because of its sensory deprivation implications may
impact memory imprints on the brain. A recent study \4\ looked at the
relationship between Tinnitus and suicide.
---------------------------------------------------------------------------
\4\ Martz et al. (2018)
---------------------------------------------------------------------------
Although symptoms can be managed, there is no cure. The National
Center for Rehabilitative Auditory Research (NCRAR) at the VA Portland
Health Care System has been involved with researching transcranial
magnetic stimulation (TMS) that involves using magnates to
nonsurgically penetrate the brain and affect the activity of neurons as
a new treatment.
Congress should request an update from the NCRAR for a
status on its research portfolio and potential translation capabilities
for TMS.
Homeless Veteran Program Data:
WoA is aware that VA administrators are intimidating VA employees
to match homeless Veterans to housing that is grossly inadequate for
the veteran and to underreport the number of homeless veterans who
cannot maintain independent living. They are using the HUD vouchers to
get homeless veterans into apartments, but then do not have the ability
to furnish or provide supplies for them. Many of these veterans are
chronically mentally ill and need more supervision than can be provided
in an apartment. The veteran fails to conduct appropriate hygiene, so
neighbors complain to landlords who evict these veterans. The VA case
manager should be recording these veterans as homeless, but instead are
told to document these veterans as transferring and not to report
anything until they get the veteran into new housing. Additionally,
over $1 billion has been provided to community organizations via
Supportive Services to Veterans Families (SSVF) grants, with little to
no performance data produced.
There needs to be greater accountability for this highly vulnerable
population.
Congress should require VA to closely document the needs
of each homeless veteran, match him or her with the appropriate type of
facility, and enhance case manager assistance with ongoing issues while
the veteran is transitioning from homelessness.
VA should conduct a long-term ``lifecycle'' study on
homeless veterans to identify challenges, complex medical/mental/dental
needs and account for accurate touchpoints for interventions, services
and outcomes of these engagements.
VA should be required to report data regarding the number
of veterans placed in transitional housing and the number who
subsequently leave and the reasons why they left housing. It should
also collect and report SSVF outcome data. Congress should authorize VA
to conduct a comprehensive review of the Homeless Veteran population
and a needs assessment.
Toxic Exposures and Environmental Hazards Research and Presumption:
Agent Orange: A primary source of concern for veterans that have
contacted WoA has been related to toxic exposures and environmental
hazards. There are still so many Vietnam-era Veterans with Agent Orange
related issues that have not been appropriately recognized because of
the shortfalls in the research, such as Blue Water Navy. For example,
eye cancers are a continuous issue that lack research support. VA
continues to deny claims for disability benefits, which in turn blocks
veteran from accessing care. As the Vietnam generation ages and has
more complex needs for care, the arguments over probable correlations
need to be resolved before there is no one left for the science to
help.
Gulf War Illness: Although it has been more than 25 years since the
US invaded Iraq, the mysteries of Gulf War Illnesses haunt veterans
while perplexing VA. A July 2017 GAO report concluded that VA is still
inappropriately denying veterans claims. It found an 80 percent denial
rate, which is three times greater than any other type of claim
denials. Plus, it also took VA longer to adjudicate these benefits.
This delay means that sick veterans are not fully eligible for VA
health care. VA has promised better training and to develop a new plan
for research.
Fort McClellan: When the Veterans Disability Benefits Commission
(VDBC) issued its report, \5\ it included the Service members (mostly
women) from Ft. McClellan, AL in its recommendation for a presumption
framework. The VDBC made 20 recommendations for improvements to the VA
presumption process, the creation of a scientific review board, and
veteran health surveillance. Over 10 years later, the American Legion
is still reporting on the ``unknown toxic legacy'' of Anniston and has
resolutions that requires a toxic substance national research center,
comprehensive examinations for environmental exposures, and improvement
in these rules. \6\
---------------------------------------------------------------------------
\5\ VDBC. Honoring the Call to Duty: Veterans Disability Benefits
in the 21st Century. October 2007.
\6\ Olsen, K. the long shadow of Ft. McClellan. The American Legion
Magazine. March 2018. Pgs. 22-28
Camp LeJeune: Due to the water contamination at the Marine Corps
Base, Camp LeJeune, NC, increased reports of cancers in veterans and
their families have been document over the last several decades related
to the cleaning solvents in the water. Referring to the previous notes
on Ft. McClellan and the VDBC findings, VA would be better situated to
address these issues if they were to have a standardized process and
---------------------------------------------------------------------------
scientific review board.
Burn Pit Exposures: Similar to previous generations of veterans,
those who have served in Afghanistan and Iraq since 9/11 were exposed
to a concoction of burning substances on military installations that
has caused them to raise health concerns from cancers to respiratory
and gastrointestinal disorders. Although VA denies conclusive research
for these conditions and does not have a presumption for burn pits, it
has established a registry. However, this is an area yet again that the
VDBC recommendation could be informative and assistive to veterans'
wellness if implemented. A registry alone assists no one.
Mandate VA to establish a Scientific Review Board as
described by the VDBC for use in considering presumptions related to
exposures. A standard should be adapted for ``causal effect'' based on
more likely than not broad spectrum of evidence that is either
Sufficient, Equipoise and above, Equipoise and below, Against. This
calculation should include relative risk assessment, epidemiology,
registries, surveillance data, predictive algorithms and interfaces
with DoD.
Research Waste, Fraud and Abuse:
WoA has reviewed complaints related to the waste, fraud and abuse
of research program funds that have gone to universities and other
private sector partners. In these cases, VA failed to provide proper
oversight of government funds or property and could not account for
items issued to non-government researchers or other staff. Property
that should have been returned to the government was not and funds
unexecuted were not returned.
Much of the $1.9 billion of taxpayer funded VA Research falls
outside of the realm of ``Direct Veteran Patient Care.'' There exist
little or no oversight to monitor these VA funded research activities.
VA Medical Centers Research dollars and facility resources are often
redistributed towards gaps in Veteran care services, which leads to a
disparaged and fractured research work environment. These are dedicated
VA laboratory research spaces intended to support VA funded research
that take place at more than 80 VA research facilities nationwide. The
VA remedy is the wholesale issuance of ``100% Off Site Waivers'' to the
Academic Affiliate.'' VA Rules and Regulations stipulate that ``All VA
Funded Grant Activity must take place on VA owned property.'' Local VA
``Nonprofit research Corporations'' (NPC's) no longer route Veteran-
centric research grant funding through VA and millions of dollars of
research equipment and space are abandoned to sit fallow. As a result,
a ``Boondoggle'' is created to support an illusion of ``Activity and
Accountability'' as once noted by Congressman Mike Coffman. The end
result is displaced VA equipment infrastructure, lost technology
transfer opportunities, royalties and invention disclosure as reported
in a recent GAO report. \7\
---------------------------------------------------------------------------
\7\ GAO-18-325: Published: Apr 25, 2018.
---------------------------------------------------------------------------
The OIG has conducted several investigations into VA research and
development and has time and time again found mismanagement issues. For
example, it investigated the development of a mobile application by VA
and found that there were 80 potential contracts totaling over $1
billion and VA did not ``pick and stick'' to the line item
appropriation, thereby executing funds without the proper congressional
authorities and confusing technology and patient care funds. In another
investigation, the OIG found that VA did not have proper safeguards
with its data when sharing information with external entities, such as
universities.
Considering these research deficits and the lack of VA's
accountability for mismanagement and mishandling of equipment and space
in its research program, VA should immediately put forth a plan for
research oversight and its ability to report on executed research
funds.
Jacqueline Garrick is a former Army social work officer who has
worked in the Departments of Veterans Affairs and Defense as well as
for the House Veterans Affairs Committee. She is a subject matter
expert in mental health and program evaluation. She is an advocate for
disabled veterans and the use of peer support to improve resilience in
traumatized populations. She founded Whistleblowers of America in 2017
based on her experience reporting attempted fraud with DoD Suicide
prevention funds.
Whistleblowers of America is a 501C3, EIN 82-3989539. Its mission
is to provide peer support to employees and veterans who have reported
wrongdoing and experienced retaliation.
Contact:
Jacqueline Garrick
[email protected]
202-309-1870
National Association of Veterans' Research and Education Foundations
(NAVREF)
May 23, 2018
US House of Representatives
House Committee on Veterans' Affairs
335 Cannon House Office Building
Washington, DC 20515
To the Committee Staff:
In regard to the hearing held May 17th on the Department of
Veterans Affairs' medical and research prosthetic program, we would
like to make an addition to the hearing record. Representative Poliquin
asked Ms. Rusconi about the handling of unspent funds from an NIH
research award. We would like to add the following statement to Ms.
Rusconi's response:
It should be noted that funds drawn from an NIH or other federal
grant by an NPC include the federally negotiated indirect rate to
administer those funds. Those administrative funds are used to support
the NPC, whose sole mission is to support VA research.
Thank you for holding this important hearing and giving NAVREF the
opportunity to represent the perspective of the VA-affiliated nonprofit
corporations.
Respectfully,
Richard P. Starrs
Chief Executive Officer
Robin Rusconi
Chairperson
[all]